Input or output interoperability
DICOM is explicitly referenced in the described input, output, or workflow.
exact submission · checked 2026-09-01The model card does not establish every supported DICOM object, transfer method, or local interface.
FDA-cleared profile
SubtleHD-CT (1.x)
Subtle Medical, Inc.
Authorized purpose: Process and enhance CT images from any CT scanner manufacturer or model as an adjunct to the original reconstructed image.
Evidence status: each field states its source quality, applicability, and review date. Research pending, information not established, and vendor documentation pending remain distinct outcomes.
Product overview
Start with the essentials
Authorized purpose: Process and enhance CT images from any CT scanner manufacturer or model as an adjunct to the original reconstructed image.
Overview status: Source-reviewed overview
- What does this software do? Authorized purpose: Process and enhance CT images from any CT scanner manufacturer or model as an adjunct to the original reconstructed image.
- Which images or clinical context are in scope? Modality: CT/CTA Anatomy or clinical context: Multiple CT anatomies: abdomen, C-spine, cardiac, chest, chest-abdomen-pelvis, head, head/neck, L-spine, lower extremity, MSK, T-spine, and upper extremity. Input: Primary reconstructed DICOM CT images sent by a technologist through a compatible MDDS; FBP primary reconstructions at standard or higher dose were quantitatively validated. The packet also includes varied scanners, anatomies, contrast, reconstruction methods, and slice thicknesses, but warns that IR/DL reconstruction performance may be unknown.
- Who uses it? Intended users: Radiologists.
- What does the software produce? Output: Enhanced DICOM CT images returned through the compatible MDDS to PACS or another DICOM node; enhanced images coexist with the original reconstructed images; no user interface.
- What is its most important limitation? Key limitation: Output interpretation is adjunctive to the original reconstructed image. Use with iterative reconstruction or deep-learning reconstructions may have unknown performance; advanced third-party post-processing or specialized non-standard filtering was not specifically characterized, and direct primary scanner reconstructions are recommended.
Clinical takeaway
Clinical role: Process and enhance CT images from any CT scanner manufacturer or model as an adjunct to the original reconstructed image.
Evidence takeaway
Evidence from the reviewed source record: FDA K254120 reports phantom performance validation using ACR, Digital CatPhan 600, and Mercury 4.0 phantoms plus a 270-case retrospective reader study. Phantom endpoints included detectability index, noise magnitude, NPS, CT-number accuracy, non-uniformity, and TTF, all reported as passing their stated criteria. Reader endpoints were diagnostic utility (average Likert score >=3) and artifact presence (average score >=2); no sensitivity/specificity or disease-detection accuracy was reported.
Clinical details
What this tool is for
Start with the authorized purpose, then verify how it fits your service line and reading workflow.
- Exact purpose
- Process and enhance CT images from any CT scanner manufacturer or model as an adjunct to the original reconstructed image.
- Intended users
- Radiologists.
- Care setting and population
- Medical facilities including hospitals, clinics, and imaging centers; the reader dataset included adult and pediatric subjects.
- Workflow role
- Background post-processing image enhancement with adjunctive radiologist review.
- Required input
- Primary reconstructed DICOM CT images sent by a technologist through a compatible MDDS; FBP primary reconstructions at standard or higher dose were quantitatively validated. The packet also includes varied scanners, anatomies, contrast, reconstruction methods, and slice thicknesses, but warns that IR/DL reconstruction performance may be unknown.
- Output and human action
- Enhanced DICOM CT images returned through the compatible MDDS to PACS or another DICOM node; enhanced images coexist with the original reconstructed images; no user interface.
- Limitations
- Output interpretation is adjunctive to the original reconstructed image. Use with iterative reconstruction or deep-learning reconstructions may have unknown performance; advanced third-party post-processing or specialized non-standard filtering was not specifically characterized, and direct primary scanner reconstructions are recommended.
Regulatory identity
FDA record and catalog context
The FDA listing establishes the regulatory identity. It does not by itself establish local workflow fit, pricing, security, or performance in your environment.
- FDA submission
- K254120
- Modality
- CT/CTA
- Anatomy
- Multiple CT anatomies: abdomen, C-spine, cardiac, chest, chest-abdomen-pelvis, head, head/neck, L-spine, lower extremity, MSK, T-spine, and upper extremity.
- Clearance type
- 510(k)
- Decision date
- 2026-05-15
- FDA status
- FDA-cleared
Implementation
Questions for IT, informatics, and operations
Use these fields to structure a vendor demo, security review, and implementation estimate.
- Integration
- Technologist routes the study from the CT scanner to a compatible MDDS via DICOM; the MDDS supplies images to SubtleHD-CT and returns enhanced images to PACS or another DICOM node using an AE Title.
- Deployment and data flow
- Vendor documentation pending
The reviewed sources do not establish the current exact-release hosting topology, data flow, region, tenancy, or disaster-recovery configuration.
- Security and privacy
- Vendor documentation pending
Exact-release security controls, data retention, hosting boundaries, and scoped assurance documentation require vendor confirmation.
- Training and support
- Vendor documentation pending
Current training prerequisites, competency checks, and support commitments for the exact configuration require vendor confirmation.
- Monitoring and change control
- Vendor documentation pending
Current drift, quality, uptime, alert, escalation, and incident-response commitments for the exact configuration require vendor confirmation.
Result destination
PACS is explicitly referenced as a result destination.
exact submission · checked 2026-09-01Confirm supported products, versions, routing behavior, and display requirements during local evaluation.
ACR exact-submission catalog context
ACR AI Central provides an exact-submission model card for SubtleHD-CT (1.x); FDA labeling remains controlling for clinical use, limitations, and performance.
exact submission · checked 2026-09-08Evidence
Performance evidence
Metrics are shown only when they are tied to a source, endpoint, population, and tested product version. Candidate literature without exact product and version linkage is not shown as product evidence.
- Evidence summary
- FDA K254120 reports phantom performance validation using ACR, Digital CatPhan 600, and Mercury 4.0 phantoms plus a 270-case retrospective reader study. Phantom endpoints included detectability index, noise magnitude, NPS, CT-number accuracy, non-uniformity, and TTF, all reported as passing their stated criteria. Reader endpoints were diagnostic utility (average Likert score >=3) and artifact presence (average score >=2); no sensitivity/specificity or disease-detection accuracy was reported.
- Reported sensitivity
- Research pending
This field has not been curated yet.
- Reported specificity
- Research pending
This field has not been curated yet.
No contextualized exact-version metric has completed evidence review. Regulatory-document values, when available, are shown above with their limitations.
SubtleHD-CT (1.x) regulatory performance study summary
- DesignReader Study
- PopulationAdult and Pediatric
- Scopeexact submission
- Tested versionExact product version not reported; regulatory study summarized for FDA submission K254120
- IndependenceIndependence not established
K254120
ACR AI Central summarizes the regulatory study; consult the exact FDA materials before comparative use.
Costs and setup
Budget and ongoing governance
These are common procurement questions; unknown values remain visible until a source supports them.
- Pricing and total cost
- Vendor documentation pending
No public price or quote for the exact K254120 configuration was established in this review.
- Reimbursement and coding
- Not established in reviewed sources
No exact-product payer policy, coding instruction, or payment determination was established; eligibility must be evaluated by payer, site of service, and use case.
Safety and lifecycle
Postmarket record
Recall and adverse-event records are shown only after product matching. Adverse-event reports do not establish incidence or causality.
- Postmarket safety review
- The exact-identifier FDA recall query returned no native recall record for K254120. This limited result does not establish absence of recalls or other safety information and does not cover later versions, family records, MAUDE reports, corrections, or field notices.
Buyer worksheet
Open questions to take to the vendor
- Verify deployment and data flow: The reviewed sources do not establish the current exact-release hosting topology, data flow, region, tenancy, or disaster-recovery configuration.
- Verify security and privacy controls: Exact-release security controls, data retention, hosting boundaries, and scoped assurance documentation require vendor confirmation.
- Verify training: Current training prerequisites, competency checks, and support commitments for the exact configuration require vendor confirmation.
- Verify pricing and total cost: No public price or quote for the exact K254120 configuration was established in this review.
- Verify reimbursement and coding relevance: No exact-product payer policy, coding instruction, or payment determination was established; eligibility must be evaluated by payer, site of service, and use case.
- Verify local validation and lifecycle monitoring: Current drift, quality, uptime, alert, escalation, and incident-response commitments for the exact configuration require vendor confirmation.
Research record
What has been checked
This audit distinguishes completed source review from fields that have not yet been researched.
Exact FDA record reviewedStatus
2026-09-20Last searched
23Fields reviewed
9Source classes checked
0Screened PubMed leads
0Screened trial leads
0Unreviewed FDA recall leads
The refreshed discovery snapshot contains no PubMed or ClinicalTrials.gov candidates; no external evidence was promoted. The current discovery snapshot contains 0 PubMed and 0 ClinicalTrials.gov candidate records; its dated, count-matched human screening remains current. Unlinked candidates remain quarantined. Native FDA recall identifiers produced 0 postmarket candidate records; 0 have been reviewed (0 published, 0 rejected) and 0 remain unreviewed.
Candidate leads were screened against the exact product and tested version. Unlinked records remain quarantined.
Source classes: fda ai list, acr ai central product, fda decision summary, fda device recall, literature index, trial registry, pubmed, clinical trials, openfda device recall
Sources & history
How this profile was documented
Open the ledger for source dates, scope, and research-record updates.
View source ledger and history
Source ledger
-
FDA K254120: SubtleHD-CT (1.x)
Scope: identity, clinicalUse, modality, anatomy, workflow, evidence, implementation
-
Artificial Intelligence-Enabled Medical Devices
Scope: regulatoryIdentity, modalityContext
-
SubtleHD-CT (1.x) model card (K254120)
Scope: intendedUsers, careSetting, output, limitations, evidenceSummary, integration, anatomy, evidenceStudies, implementationCapabilities
-
PubMed biomedical literature index
Scope: evidenceDiscovery
-
ClinicalTrials.gov study registry
Scope: evidenceDiscovery, studyStatus
-
openFDA Device Recall API
Scope: recallDiscovery, nativeSubmissionMatching
-
openFDA exact recall query for K254120
Scope: postmarketSafety
Research history
-
K254120 FDA decision
Regulatory record
510(k)
-
Source-review record updated
Research record
fda record reviewed
-
Reader overview source-reviewed
Editorial review
Source-reviewed editorial overlay
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