Radiology AI committee packet
Captured 2026-11-09T02:26:30.977Z · 2 exact FDA record(s). FDA submissions are not a count of distinct commercial offers.
A shared link opens current public data. This downloaded snapshot retains its captured data and optional private appendices.
Snapshot identity and dates
FDA dataset last verified: 2026-08-31. Each field and source relationship keeps its own review date below; capture time is not a new source review.
Public content SHA-256: 0e79701d02a2fbba6db8ae2901c7d98278db4f78200060fab738ec8bf4c97180
Packet SHA-256: 321451eaf51f82d12cef6374721d88a8021bbbe496d23726d68d3c20e3a98415
Template committee-packet-v1. Fingerprints identify captured content; they are not reviewer authentication or approval.
Decisions still needed
- Confirm the offered module, exact AI build, market authorization and population against each selected FDA record.
- Agree the clinical question, matched evaluation cases, exclusions, endpoints and clinician action. Different studies or products are not assumed equivalent.
- Obtain exact installed PACS/viewer and interface builds, supplier evidence and local acceptance results. Public reference versions do not qualify a pairing.
- Resolve every missing, conflicting, withdrawn or broader-scope fact and every quote gap before a purchasing decision.
- Validate the scenario's workload, adoption, rework, demand, removable payments, cost scope and hour allocations with operations and purchasing.
- Name clinical, IT and purchasing owners, acceptance authority, monitoring, change control, stop-use criteria and rollback. No acceptance or purchase approval is recorded by this packet.
MammoScreen® (5)
K260714 · Therapixel · Mammography/DBT · FDA-cleared · FDA decision 2026-06-26
Commercial module/version and current availability require supplier confirmation. FDA record identity does not establish the current offer.
Live profile (may change) · FDA decision sourceClinical fit and evidence limits
Anatomy
Available · Exact FDA submission · Checked 2026-09-05
Breast
Purpose
Available · Exact FDA submission · Checked 2026-09-05
Flags calcifications, masses, asymmetries and architectural distortions on compatible FFDM or DBT screening examinations; management must not be based solely on MammoScreen output.
Workflow role
Available · Exact FDA submission · Checked 2026-09-05
Concurrent reading/reporting aid; includes an initial report populated with selected findings.
Required input
Available · Exact FDA submission · Checked 2026-09-05
Compatible GE or Hologic FFDM or DBT screening exams, with optional priors; supplementary XCCM, XCCL and ML views are supported in specified scenarios.
Output and clinician action
Available · Exact FDA submission · Checked 2026-09-05
Finding-, breast- and case-level scores from 1 to 10, locations and finding marks for masses, asymmetries, distortions and calcifications.
Care setting
Available · Exact FDA submission · Checked 2026-09-05
Screening mammography workflow.
Intended users
Available · Exact FDA submission · Checked 2026-09-05
Physicians interpreting screening mammograms.
Limitations
Available · Exact FDA submission · Checked 2026-09-05
Not a standalone diagnostic device and not a substitute for physician review; the MammoScreen 5 algorithm is unchanged from MammoScreen 4.
Evidence summary
Available · Exact FDA submission · Checked 2026-09-05
Regulatory performance evidence is from the prior MammoScreen 3 clinical dataset, not a new MammoScreen 5 clinical study.
IT implementation and exact system pairings
Deployment
Available · Product family · Checked 2026-09-06
Current family documentation describes a site gateway with cloud computation and an on-premises option available on request.
Integration
Available · Product family · Checked 2026-09-06
Current MammoScreen family documentation describes a site virtual gateway, DICOM Secondary Capture and Structured Report output, and optional EMR/reporting API integration using HL7/FHIR.
Current family documentation, not evidence that every interface or package shipped with the cleared version.
Data hosting location: Not yet reviewed · check date not established
Data retention: Not yet reviewed · check date not established
Documented data use: Not yet reviewed · check date not established
Hardware requirements: Not yet reviewed · check date not established
Network requirements: Not yet reviewed · check date not established
Identity and access: Not yet reviewed · check date not established
Security
Available · Vendor-wide · Checked 2026-10-25
Therapixel's own page says Therapixel and its operations for MammoScreen are ISO/IEC 27001 certified by an independent certification body. The page gives no certificate number, scope statement, issue date or expiry, and the certificate was not read.
Vendor-wide statement, not an independent attestation. It does not establish certificate or report scope for this exact release, expiry, data location, retention, identity and access, or incident-response terms for a deployed configuration. Obtain these from the vendor.
Installation timeline: Not yet reviewed · check date not established
Training
Available · Product family · Checked 2026-09-06
The vendor offers a limited-time pilot with remote installation and training.
Duration, curriculum and applicability to version 5 are not stated.
Monitoring: Not verified · checked 2026-09-06 · No site monitoring or update-acceptance procedure was established.
System: Merge PACS
Not reviewed for this pairing · Scope: product family; geography: Geography not established for this exact pairing · Checked 2026-11-06
AI version: not established; system version: not established Scope: product family; geography: Geography not established for this exact pairing Configuration: Merge describes mammography integrations including Therapixel. The source does not identify MammoScreen 5 and a specific Merge build. Condition: A supplier-family integration statement is context, not qualification of this FDA record or site installation. Local test needed: Obtain the two exact builds, licensed interface and conformance/acceptance evidence from both suppliers. Source review: 2026-11-06 Broader product-family or vendor context. The exact AI release and system build pairing is not reviewed. Installed-system acceptance has not been performed. Public version baseline: 9.5; Public technical document; reviewed 2026-11-06. Highest version listed in Merge's public DICOM index. Regional availability and corrected patch/build need supplier confirmation. The reviewed FDA record identifies affected 9.5 software. Confirm the supplier's correction and exact build before acceptance. Reference baseline only. Installed build and AI compatibility remain to be established.
System: Visage 7: Not reviewed for this pairing. Obtain exact AI and installed system builds; local acceptance has not been performed.
System: Sectra IDS7: Not reviewed for this pairing. Obtain exact AI and installed system builds; local acceptance has not been performed.
System: AGFA Enterprise Imaging: Not reviewed for this pairing. Obtain exact AI and installed system builds; local acceptance has not been performed.
System: IntelePACS: Not reviewed for this pairing. Obtain exact AI and installed system builds; local acceptance has not been performed.
System: GE FFDM/DBT input
Conditional support · Scope: exact submission; geography: United States labeling · Checked 2026-11-06
Conditional support. AI version: MammoScreen 5; system version: not established
Configuration: FDA-labeled FFDM/DBT input from compatible GE equipment; a software build is not identified. Condition: Confirm the precise acquisition model, software, priors and supported scenarios against the release-specific labeling. Local test needed: Route representative labeled exams and verify study identity, findings, reporting and fallback review. Source review: 2026-11-06 Source documentation describes this scope; local installed-system acceptance remains open. Installed-system acceptance has not been performed.
System: Hologic FFDM/DBT input
Conditional support · Scope: exact submission; geography: United States labeling · Checked 2026-11-06
Conditional support. AI version: MammoScreen 5; system version: not established
Configuration: FDA-labeled FFDM/DBT input from compatible Hologic equipment; a software build is not identified. Condition: Confirm the precise acquisition model, software and current/prior image scenarios; do not extend the claim to every Hologic configuration. Local test needed: Test the agreed inputs and exclusions, findings, initial report and retained physician review. Source review: 2026-11-06 Source documentation describes this scope; local installed-system acceptance remains open. Installed-system acceptance has not been performed.
Public pricing scope
Not publicly available · Checked 2026-09-06
No public price or contract for MammoScreen 5 was located in the reviewed vendor material.
Fictional quote inputs and gaps
Buyer-entered, not a verified public price · Scope not confirmed · saved not saved
- Offered module
- FICTIONAL scope placeholder, not a supplier offer
- Offered software version
- FICTIONAL release, not mapped to the FDA record
- Country or market
- Not stated
- Currency
- Not stated
- Quote date
- Not stated
- Valid until (if stated)
- Not stated
- Bundle and exclusions
- Not stated
- Volume and pricing basis
- Not stated
- Minimum commitment
- Not stated
- Support terms
- Not stated
- Upgrade terms
- Not stated
- Renewal terms
- Not stated
- Termination terms
- Not stated
- Exit and data handoff
- Not stated
- Conflicting terms or amounts
- Not stated
| K260714 · FICTIONAL quote inputs | ||||
|---|---|---|---|---|
| Cost | Status | Amount | Billed unit | Scope/reason |
| Base license | Not confirmed | Amount not confirmed | Unit not stated | Not stated |
| Setup and implementation | Not confirmed | Amount not confirmed | Unit not stated | Not stated |
| Interfaces and gateways | Not confirmed | Amount not confirmed | Unit not stated | Not stated |
| Hardware and compute | Not confirmed | Amount not confirmed | Unit not stated | Not stated |
| Other recurring costs | Not confirmed | Amount not confirmed | Unit not stated | Not stated |
| Support charges | Not confirmed | Amount not confirmed | Unit not stated | Not stated |
| Upgrade charges | Not confirmed | Amount not confirmed | Unit not stated | Not stated |
| Exit and migration charges | Not confirmed | Amount not confirmed | Unit not stated | Not stated |
Quote issues remain before purchasing review.
- Country or market
- Currency
- Quote date
- Bundle and exclusions
- Volume and pricing basis
- Minimum commitment
- Support terms
- Upgrade terms
- Renewal terms
- Termination terms
- Exit and data handoff
- Exact offer applicability
- Quote/contract conflict check
- Base license: confirm whether charged, included or not applicable
- Setup and implementation: confirm whether charged, included or not applicable
- Interfaces and gateways: confirm whether charged, included or not applicable
- Hardware and compute: confirm whether charged, included or not applicable
- Other recurring costs: confirm whether charged, included or not applicable
- Support charges: confirm whether charged, included or not applicable
- Upgrade charges: confirm whether charged, included or not applicable
- Exit and migration charges: confirm whether charged, included or not applicable
Captured sources
Transpara (2.1.0)
K241831 · ScreenPoint Medical B.V. · Mammography/DBT · FDA-cleared · FDA decision 2024-11-25
Commercial module/version and current availability require supplier confirmation. FDA record identity does not establish the current offer.
Live profile (may change) · FDA decision sourceClinical fit and evidence limits
Anatomy
Available · Exact FDA submission · Checked 2026-09-04
Breast; regions suspicious for cancer on screening mammography and digital breast tomosynthesis
Purpose
Available · Exact FDA submission · Checked 2026-09-04
Transpara 2.1.0 is a concurrent reading aid for physicians interpreting screening full-field digital mammography and digital breast tomosynthesis, providing region and examination scores to support review of suspicious breast findings.
Workflow role
Available · Exact FDA submission · Checked 2026-09-04
Concurrent reading aid for screening mammography and DBT interpretation.
Required input
Available · Exact FDA submission · Checked 2026-09-04
DICOM full-field digital mammography and digital breast tomosynthesis examinations from compatible systems.
Output and clinician action
Available · Exact FDA submission · Checked 2026-09-04
DICOM mammography CAD results with marked calcification groups, soft-tissue regions, region scores, and an examination score.
Care setting
Available · Exact FDA submission · Checked 2026-09-04
Healthcare facilities performing screening mammography and digital breast tomosynthesis.
Intended users
Available · Exact FDA submission · Checked 2026-09-04
Physicians qualified to interpret screening mammography and digital breast tomosynthesis.
Limitations
Available · Exact FDA submission · Checked 2026-09-04
The FDA labeling states that the output is not the sole basis for patient management. Use is limited to compatible screening FFDM and DBT and requires physician review; the software does not replace interpretation.
Evidence summary
Available · Exact FDA submission · Checked 2026-09-04
K241831 FDA decision material reports the exact evidence metrics included below for Transpara 2.1.0; values are limited to the stated endpoint, population, and operating point.
IT implementation and exact system pairings
Deployment
Available · Exact FDA submission · Checked 2026-09-04
The FDA package describes a standalone processing appliance with a third-party workstation interface; current hosting, contracts, availability, security, and site configuration remain unknown.
Integration
Available · Exact FDA submission · Checked 2026-09-04
The FDA package describes DICOM mammography input and CAD output to a workstation, PACS, or RIS through a standalone processing appliance and third-party workstation interface.
Data hosting location: Not yet reviewed · check date not established
Data retention: Not yet reviewed · check date not established
Documented data use: Not yet reviewed · check date not established
Hardware requirements: Not yet reviewed · check date not established
Network requirements: Not yet reviewed · check date not established
Identity and access: Not yet reviewed · check date not established
Security
Available · Vendor-wide · Checked 2026-10-25
ScreenPoint Medical's security reporting page states its security program is aligned with ISO/IEC 27001 and describes a vulnerability reporting channel for Transpara. It states alignment, not certification; no controls are listed. Vendor-wide.
Vendor statement, not an attestation; exact-release scope is not established.
Installation timeline: Not yet reviewed · check date not established
Training
Available · Exact FDA submission · Checked 2026-09-04
Use by physicians qualified to interpret screening mammography and digital breast tomosynthesis. Follow the exact labeling, local training, supervision, and escalation requirements.
Monitoring
Available · Exact FDA submission · Checked 2026-09-04
Monitor labeled population, acquisition quality, exclusions, reviewer overrides, failures, and downstream workflow effects for K241831.
System: Merge PACS: Not reviewed for this pairing. Obtain exact AI and installed system builds; local acceptance has not been performed.
System: Visage 7: Not reviewed for this pairing. Obtain exact AI and installed system builds; local acceptance has not been performed.
System: Sectra IDS7
Not reviewed for this pairing · Scope: product family; geography: Geography not established for this exact pairing · Checked 2026-11-06
AI version: not established; system version: not established Scope: product family; geography: Geography not established for this exact pairing Configuration: Sectra lists Transpara results in IDS7, MG CAD SR/SC, overlays and worklist integration. The compatible PACS version must be confirmed. Condition: The marketplace listing does not bind Transpara 2.1.0 in K241831 to a named IDS7 build. Local test needed: Confirm the AI release, IDS7/Core build, licensed integration and region, then test marks, scores, workflow and failure handling. Source review: 2026-11-06 Broader product-family or vendor context. The exact AI release and system build pairing is not reviewed. Installed-system acceptance has not been performed. Public version baseline: 28.2; Announced version; availability unconfirmed; reviewed 2026-11-06. Sectra's public program names IDS7 28.2 for a December 8, 2026 webinar. This establishes an announced version, not general availability or a site build. The public March 2026 conformance statement covers 28.1. Reference baseline only. Installed build and AI compatibility remain to be established.
System: AGFA Enterprise Imaging: Not reviewed for this pairing. Obtain exact AI and installed system builds; local acceptance has not been performed.
System: IntelePACS: Not reviewed for this pairing. Obtain exact AI and installed system builds; local acceptance has not been performed.
System: GE FFDM/DBT input: Not reviewed for this pairing. Obtain exact AI and installed system builds; local acceptance has not been performed.
System: Hologic FFDM/DBT input: Not reviewed for this pairing. Obtain exact AI and installed system builds; local acceptance has not been performed.
Public pricing scope
Not publicly available · Checked 2026-09-04
No public list price or commercial contract for the exact submission and version was identified.
Fictional quote inputs and gaps
No private quote attached. Offered scope, costs and contract terms remain unconfirmed.
Quote issues remain before purchasing review.
- Offered module
- Offered software version
- Country or market
- Currency
- Quote date
- Bundle and exclusions
- Volume and pricing basis
- Minimum commitment
- Support terms
- Upgrade terms
- Renewal terms
- Termination terms
- Exit and data handoff
- Exact offer applicability
- Quote/contract conflict check
- Base license: confirm whether charged, included or not applicable
- Setup and implementation: confirm whether charged, included or not applicable
- Interfaces and gateways: confirm whether charged, included or not applicable
- Hardware and compute: confirm whether charged, included or not applicable
- Other recurring costs: confirm whether charged, included or not applicable
- Support charges: confirm whether charged, included or not applicable
- Upgrade charges: confirm whether charged, included or not applicable
- Exit and migration charges: confirm whether charged, included or not applicable
Captured sources
Local acceptance tasks
- Data path: Document input routing, gateways, identifiers, de-identification and every destination.
- Output destination: Verify object types, overlays, measurements, report location and access to the original images.
- Latency and failures: Agree a workload and turnaround target; test queues, timeouts, missing results and fallback reading.
- Security documents: Review hosting, retention, access, audit logs, incident handling and required contractual documents.
- Ownership: Name the clinical, IT and vendor owners, acceptance authority and support escalation path.
- Training: Confirm reader/admin training, known limitations and how to correct or override outputs.
- Updates and rollback: Define version change control, revalidation triggers, stop-use criteria and a tested rollback route.
Public system reference appendix
These dated references do not establish your installed or corrected build, commercial availability, or an AI pairing.
Merge PACS
Public version baseline: 9.5; Public technical document; reviewed 2026-11-06.
Highest version listed in Merge's public DICOM index. Regional availability and corrected patch/build need supplier confirmation.
The reviewed FDA record identifies affected 9.5 software. Confirm the supplier's correction and exact build before acceptance.
Reference baseline only. Installed build and AI compatibility remain to be established.
Visage 7
Public version baseline: 7.1.21; Announced version; availability unconfirmed; reviewed 2026-11-06.
Visage's October 15, 2026 announcement names 7.1.21 for demonstration. General availability and region/build are not established; digital-pathology diagnostic use is described as work in progress.
Reference baseline only. Installed build and AI compatibility remain to be established.
Sectra IDS7
Public version baseline: 28.2; Announced version; availability unconfirmed; reviewed 2026-11-06.
Sectra's public program names IDS7 28.2 for a December 8, 2026 webinar. This establishes an announced version, not general availability or a site build. The public March 2026 conformance statement covers 28.1.
Reference baseline only. Installed build and AI compatibility remain to be established.
AGFA Enterprise Imaging
Public version baseline: 8.4.4; Public technical document; reviewed 2026-11-06.
AGFA's current public IHE statement, revision 12, names 8.4.4 (October 2025). Exact service build, regional availability and newer private releases need supplier confirmation.
Reference baseline only. Installed build and AI compatibility remain to be established.
IntelePACS
Public version baseline: 5.9.1; Regulatory identification; corrected build unconfirmed; reviewed 2026-11-06.
The October 2026 FDA record identifies IntelePACS 5.9.1 among affected portal releases. This is the highest public release found, not evidence of the latest corrected patch or general availability.
The record concerns portal report/image matching with specified Chromium browsers. Confirm the corrected portal build and browser configuration with the supplier.
Reference baseline only. Installed build and AI compatibility remain to be established.
Optional buyer scenario appendix
Buyer-supplied assumptions. This does not verify a product's performance, quote or relationship to these FDA records.
FICTIONAL facility example of the appendix format only. This scenario is not mapped to either selected FDA record and establishes no product-specific performance or price.
Calculation interpretation-capacity-v1 · annual horizon · exported 2026-11-09T02:26:30.977Z
| FICTIONAL FACILITY ASSUMPTIONS · interpretation-capacity-v1 · no product performance or price verified | |||
|---|---|---|---|
| Result | low | base | high |
| Capacity | 0 hours/year | 100 hours/year | 300 hours/year |
| Hours for expense removal | 0 hours/year | 0 hours/year | 0 hours/year |
| Hours for extra exams | 0 hours/year | 100 hours/year | 300 hours/year |
| Additional completed exams | 0 exams/year | 120 exams/year | 120 exams/year |
| Avoidable expense | 0 USD/year | 0 USD/year | 0 USD/year |
| Annual cash benefit | 0 USD/year | 3,000 USD/year | 3,000 USD/year |
| Annual net benefit | -1,500 USD/year | 1,500 USD/year | 1,500 USD/year |
| First-year net | -2,500 USD | 500 USD | 500 USD |
| First-year ROI | -100 % | 20 % | 20 % |
| Simple payback | Not established | 8 months | 8 months |
low unresolved checks and limits
- Payback unavailable: annual net cash benefit is not positive.
base unresolved checks and limits
No calculation-input warnings in this case. Inputs remain unverified.
high unresolved checks and limits
No calculation-input warnings in this case. Inputs remain unverified.
Zero cash-benefit first-year net: -2,500 USD
Frozen input snapshot and origins
- Offered module
- FICTIONAL interpretation workflow
- Offered software version
- FICTIONAL 1
- Currency
- USD
- Benefit mechanism/evidence
- FICTIONAL demand and staffing assumptions for the sample appendix only; not measured for either selected product.
- Cost scope/conversions
- FICTIONAL complete one-time and annual costs; no product price is asserted.
- Benefit mechanism
- Additional completed exams
- All material costs accounted for
- Buyer confirmed
Common inputs
- Eligible annual exams (exams/year)
- 12000 · Buyer-entered assumption
- Baseline interpretation time (seconds/exam)
- 600 · Buyer-entered assumption
- One-time implementation and capital costs (currency, once)
- 1000 · Buyer-entered assumption
- Annual recurring supplier costs (currency/year)
- 1000 · Buyer-entered assumption
- Annual additional operating costs (currency/year)
- 500 · Buyer-entered assumption
- Hours allocated to expense avoidance (% of positive capacity)
- Not stated
- Avoidable annual cash expense (currency/year)
- Not stated
- Annual hours required to remove that expense (hours/year)
- Not stated
- Unmet eligible annual demand (exams/year)
- 250 · Buyer-entered assumption
- Feasible additional exams per saved hour (exams/hour)
- 4 · Buyer-entered assumption
- Available annual scanner slots (additional exams/year)
- 180 · Buyer-entered assumption
- Available staffing and downstream capacity (additional exams/year)
- 120 · Buyer-entered assumption
- Contribution margin per additional exam (currency/exam)
- 25 · Buyer-entered assumption
low inputs
- Gross time saved (seconds/exam)
- 30 · Buyer-entered assumption
- Additional rework time (seconds/exam)
- 30 · Buyer-entered assumption
- Adoption (% of eligible exams)
- 50 · Buyer-entered assumption
base inputs
- Gross time saved (seconds/exam)
- 90 · Buyer-entered assumption
- Additional rework time (seconds/exam)
- 30 · Buyer-entered assumption
- Adoption (% of eligible exams)
- 50 · Buyer-entered assumption
high inputs
- Gross time saved (seconds/exam)
- 150 · Buyer-entered assumption
- Additional rework time (seconds/exam)
- 30 · Buyer-entered assumption
- Adoption (% of eligible exams)
- 75 · Buyer-entered assumption
Calculation formulas
- Net seconds saved/exam = gross seconds saved − additional rework seconds.
- Annual capacity hours = eligible annual exams × net seconds saved/exam × adoption percent / 100 / 3600. Negative hours mean added workload.
- Positive hours = max(0, capacity hours). Allocate all to the chosen cash path, or partition by the stated percent. Capacity-only hours have no cash value assigned.
- Avoidable cash expense = target expense only when allocated cash hours ≥ required annual hours; otherwise 0. Reserved cash hours cannot also support extra exams.
- Additional completed exams = floor(max(0, min(unmet annual demand, allocated exam hours × feasible exams/hour, available scanner slots, staffing/downstream capacity))).
- Annual cash benefit = avoidable cash expense + additional completed exams × contribution margin/exam.
- Annual net benefit = annual cash benefit − annual recurring supplier costs − annual additional operating costs.
- First-year net = annual net benefit − one-time implementation/capital costs. First-year ROI percent = first-year net / complete first-year costs × 100, only if costs > 0.
- Simple payback months = one-time costs / (positive annual net benefit / 12). It assumes steady annual cash flow, with no discounting, tax, financing or ramp-up model.
- Zero cash-benefit check: first-year net = −(one-time + annual recurring + annual operating costs). It assumes no realized cash benefit, even if capacity improves.