Radiology AI Directory

FDA-cleared profile

aPROMISE

EXINI Diagnostics AB

Authorized purpose: aPROMISE is a cloud-based platform for healthcare professionals and researchers to accept, transfer, store, display, manipulate, quantify, and report PSMA PET/CT examinations using the PROMISE framework.

Prostate imagingQuantification and segmentationNuclear medicine
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: aPROMISE is a cloud-based platform for healthcare professionals and researchers to accept, transfer, store, display, manipulate, quantify, and report PSMA PET/CT examinations using the PROMISE framework.

Overview status: Source-reviewed overview

Clinical takeaway

Clinical role: aPROMISE is a cloud-based platform for healthcare professionals and researchers to accept, transfer, store, display, manipulate, quantify, and report PSMA PET/CT examinations using the PROMISE framework.

Evidence takeaway

Evidence from the reviewed source record: K211655 reports phantom validation, predicate comparison, analytical performance, and a clinical study comparing platform-supported PSMA PET/CT quantification with clinician assessment. The FDA summary does not provide one universal sensitivity or specificity value; exact tracer, acquisition, and version applicability must be checked before using candidate publications as performance evidence.

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
aPROMISE is a cloud-based platform for healthcare professionals and researchers to accept, transfer, store, display, manipulate, quantify, and report PSMA PET/CT examinations using the PROMISE framework.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-19

Clinical-use display mirrors the exact FDA-supported purpose reconciled from the decision-summary packet.

Intended users
Healthcare professionals and researchers.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-19

This is the exact intended-user class in the indication statement; the current qualified-specialist role list is not stated.

Care setting and population
Molecular-imaging departments or validated research workflows using supported DICOM PET/CT examinations.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-03
Workflow role
PET/CT visualization, segmentation, quantification, quality control, and structured reporting support.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-03
Required input
PSMA PET/CT image data in the form of DICOM files.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-19

The direct packet input statement replaces the current radiopharmaceutical-metadata addition.

Output and human action
The review page displays studies in a 4-panel view showing PET, CT, PET/CT fusion and maximum intensity projection (MIP) simultaneously. Selected or drawn hotspots are subject to automatic quantitative analysis. Signed reports are saved in the device and can be exported as a JPG or DICOM file.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-19

The exact packet supports PET/CT visualization, hotspot analysis, quantitative analysis, and signed-report export; it does not state the current disease-burden wording.

Limitations
Both aPROMISE and the predicate aBSI rely on the user to make the final selection of regions of interest that are considered as lesions. To create a report the signing user is required to confirm quality control, and electronically sign the report preview.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-19

These are the packet's direct user-confirmation and report-quality-control boundaries; tracer, acquisition, reconstruction, and literature limitations are not stated in this packet.

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
K211655
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Modality
PET/SPECT/Nuclear Medicine
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-19

The packet identifies NM imaging using PSMA PET/CT and does not establish the current SPECT expansion. Controlled directory display reconciled from exact FDA wording: Nuclear medicine (NM) imaging using PSMA PET/CT. -> PET/SPECT/Nuclear Medicine.

Anatomy
Prostate
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-19

The packet directly refers to body scans; it does not state prostate anatomy in the reviewed indication or summary. Controlled directory display reconciled from exact FDA wording: Body scans of PSMA PET/CT image data. -> Prostate.

Clearance type
510(k)
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Decision date
2021-07-27
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
FDA status
FDA-cleared
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31

Implementation

Questions for IT, informatics, and operations

Use these fields to structure a vendor demo, security review, and implementation estimate.

Integration
K211655 describes DICOM transfer, a four-panel PET/CT/fusion/MIP display, ROI quantification, user quality control, electronic report confirmation, and archival workflow. Current EXINI or PYlarify material is product-family context and does not prove the exact deployed cloud configuration.
  • Public source
  • Product family
  • Checked 2026-09-03

Current vendor materials are product-family evidence for K211655; confirm the exact cleared version, enabled options, deployment, and local compatibility.

Deployment and data flow
Cloud-based web platform as described in K211655; confirm hosting region, tenant isolation, identity, retention, and current product build with the vendor.
  • Public source
  • Product family
  • Checked 2026-09-03

Current vendor materials are product-family evidence for K211655; confirm the exact cleared version, enabled options, deployment, and local compatibility.

Security and privacy
Vendor documentation pending
  • Vendor confirmation
  • Exact FDA submission
  • Checked 2026-09-03

Public materials reviewed for this exact release do not establish the complete security posture. Request data-flow, identity, audit, encryption, retention, remote-access, vulnerability-management, backup, and incident-response evidence.

Training and support
Only qualified nuclear medicine physicians, radiologists, and trained imaging analysts should operate or interpret the product. Local onboarding should cover the exact release, supported population, limitations, failure examples, escalation, downtime, and competency documentation.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-03
Monitoring and change control
Monitor by exact hardware, software, model, and algorithm version; patient population; anatomy; protocol; operator; input quality; output edits or overrides; failed studies; repeat acquisition or rework; downstream impact; downtime; incidents; recalls; and updates. Track these product-specific limits: Quantification depends on tracer, acquisition, reconstruction, segmentation, image quality, and user quality-control steps; candidate literature and current family materials do not establish exact-version performance unless explicitly linked to the submission.
  • Public source
  • Product family
  • Checked 2026-09-03

Current vendor materials are product-family evidence for K211655; confirm the exact cleared version, enabled options, deployment, and local compatibility.

Release and scope verification

Map the installed model, build, options, population, anatomy, inputs, outputs, and enabled AI functions to K211655 before acceptance.

exact submission · checked 2026-09-03

Later product-family features are not evidence that this cleared release includes them.

Source

Interoperability acceptance

K211655 describes DICOM transfer, a four-panel PET/CT/fusion/MIP display, ROI quantification, user quality control, electronic report confirmation, and archival workflow. Current EXINI or PYlarify material is product-family context and does not prove the exact deployed cloud configuration.

product family · checked 2026-09-03

Test representative identifiers, orientation, geometry, measurements, units, routing, failure handling, and round trips locally. Vendor statements are current product-family context; confirm the exact cleared release and installed options.

SourceSource

Clinical acceptance

Use a signed local test set for the supported population and workflow. Include common and difficult cases, exclusions, acquisition variation, failed or low-quality inputs, reviewer overrides, and downstream effects. Quantification depends on tracer, acquisition, reconstruction, segmentation, image quality, and user quality-control steps; candidate literature and current family materials do not establish exact-version performance unless explicitly linked to the submission.

exact submission · checked 2026-09-03

Define stop-use, escalation, rollback, and revalidation triggers before production use.

Source

Economic evaluation

Model capital and recurring cost against net staff time after review, throughput, repeat imaging or rework, room time, consumables, infrastructure, training, service, downtime, upgrade, and replacement costs.

product family · checked 2026-09-03

No exact-product price was found in the reviewed public material; vendor productivity claims are scenario inputs, not guaranteed local savings.

Source

Lifecycle monitoring

Monitor by exact hardware, software, model, and algorithm version; patient population; anatomy; protocol; operator; input quality; output edits or overrides; failed studies; repeat acquisition or rework; downstream impact; downtime; incidents; recalls; and updates. Track these product-specific limits: Quantification depends on tracer, acquisition, reconstruction, segmentation, image quality, and user quality-control steps; candidate literature and current family materials do not establish exact-version performance unless explicitly linked to the submission.

product family · checked 2026-09-03

Revalidate after material software, hardware, model, protocol, interface, or clinical-policy changes. Vendor statements are current product-family context; confirm the exact cleared release and installed options.

SourceSource

Evidence

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
K211655 reports phantom validation, predicate comparison, analytical performance, and a clinical study comparing platform-supported PSMA PET/CT quantification with clinician assessment. The FDA summary does not provide one universal sensitivity or specificity value; exact tracer, acquisition, and version applicability must be checked before using candidate publications as performance evidence.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-03
Reported sensitivity
Not applicable
  • Not applicable
  • Not applicable
  • Checked 2026-09-03

Sensitivity is not the primary endpoint for this system, reconstruction, segmentation, guidance, or quantitative function. Use the task-specific evidence below.

Reported specificity
Not applicable
  • Not applicable
  • Not applicable
  • Checked 2026-09-03

Specificity is not the primary endpoint for this system, reconstruction, segmentation, guidance, or quantitative function. Use the task-specific evidence below.

No contextualized exact-version metric has completed evidence review. Regulatory-document values, when available, are shown above with their limitations.

K211655 FDA performance package for aPROMISE

  • DesignManufacturer phantom, analytical, predicate-comparison, and clinical performance validation
  • PopulationPSMA PET/CT examinations for prostate-cancer imaging, quantification, and structured reporting
  • Scopeexact submission
  • Tested versionaPROMISE
  • IndependenceSponsor or vendor study

K211655

Manufacturer evidence submitted for FDA clearance or approval; local clinical, technical, and workflow acceptance remains necessary.

Source

4 unlinked candidate evidence records are retained for source review and excluded from this evidence display.

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
Not established in reviewed sources
  • Reviewed sources checked
  • Exact FDA submission
  • Checked 2026-09-03

No public list price for the exact cleared configuration was found. Obtain a written quote separating hardware or license basis, implementation, interfaces, infrastructure, training, service, upgrades, renewal, consumables, and exit costs.

Reimbursement and coding
No separate named-product Medicare payment was identified in the reviewed CMS coverage material. Evaluate the product within the applicable imaging, procedural, or surgical service line and verify payer, site-of-service, and coding assumptions independently.
  • Public source
  • Not applicable
  • Checked 2026-09-03

No product-specific code

No separate named-product payment identified in reviewed public material

Centers for Medicare & Medicaid Services · United States

Build a local total-cost and value model; do not infer reimbursement from FDA clearance or approval.

Source

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 2026-09-02 openFDA device-recall snapshot contained no record matched to K211655 by exact submission identifier. This does not exclude product-family, later, or adverse-event information.
  • Public source
  • Exact FDA submission
  • Checked 2026-09-03

Exact-identifier review does not prove absence of all product-family safety signals.

Buyer worksheet

Open questions to take to the vendor

Open evaluation checklist

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
28Fields reviewed
14Source classes checked
9Screened PubMed leads
1Screened trial leads
0Unreviewed FDA recall leads

The refreshed discovery snapshot contains 9 PubMed and 1 ClinicalTrials.gov candidate records. Discovery metadata alone does not establish exact tested-product, version, population, and endpoint applicability, so all candidates remain quarantined and none was promoted. The current discovery snapshot contains 9 PubMed and 1 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, fda decision summary, fda decision material, vendor product page, peer reviewed literature, clinical trial registry, reimbursement policy, fda device recall, fda decision summary packet, 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

  1. FDA K211655: aPROMISE

    U.S. Food and Drug Administration - Published 2021-07-27 - Accessed 2026-09-19

    Scope: purpose, modality, anatomy, intendedUsers, input, output, limitations, evidenceSummary, clinicalUse

  2. Artificial Intelligence-Enabled Medical Devices

    U.S. Food and Drug Administration - Accessed 2026-08-31

    Scope: regulatoryIdentity, modalityContext

  3. PubMed biomedical literature index

    U.S. National Library of Medicine - Accessed 2026-09-01

    Scope: evidenceDiscovery

  4. ClinicalTrials.gov study registry

    U.S. National Library of Medicine - Accessed 2026-09-01

    Scope: evidenceDiscovery, studyStatus

  5. Medicare Coverage Database

    Centers for Medicare & Medicaid Services - Accessed 2026-09-01

    Scope: coverage, codingContext

  6. openFDA Device Recall API

    U.S. Food and Drug Administration - Accessed 2026-09-02

    Scope: recallDiscovery, nativeSubmissionMatching

  7. EXINI aPROMISE product-family context

    EXINI Diagnostics - Accessed 2026-09-03

    Scope: productFamilyContext, integration, deployment

  8. PSMA PET Evaluation with a Deep Learning Platform Compared with a Standard Image Viewer and Histopathology.

    U.S. National Library of Medicine - Accessed 2026-09-03

    Scope: evidenceStudies, productFamilyContext, evidenceDiscovery

  9. Comparison of diagnostic performance between manual diagnosis following PROMISE V2 and aPROMISE utilizing Ga/F-PSMA PET/CT.

    U.S. National Library of Medicine - Accessed 2026-09-03

    Scope: evidenceStudies, productFamilyContext, evidenceDiscovery

  10. Quantitative assessment of PSMA PET response to therapy in castration-sensitive prostate cancer using an automated imaging platform for disease identification and measurement.

    U.S. National Library of Medicine - Accessed 2026-09-03

    Scope: evidenceStudies, productFamilyContext, evidenceDiscovery

  11. Treatment Response Assessment According to Updated PROMISE Criteria in Patients with Metastatic Prostate Cancer Using an Automated Imaging Platform for Identification, Measurement, and Temporal Tracking of Disease.

    U.S. National Library of Medicine - Accessed 2026-09-03

    Scope: evidenceStudies, productFamilyContext, evidenceDiscovery

  12. aPROMISE: A Novel Automated PROMISE Platform to Standardize Evaluation of Tumor Burden in (18)F-DCFPyL Images of Veterans with Prostate Cancer.

    U.S. National Library of Medicine - Accessed 2026-09-03

    Scope: evidenceStudies, productFamilyContext, evidenceDiscovery

  13. Analytical performance of aPROMISE: automated anatomic contextualization, detection, and quantification of [(18)F]DCFPyL (PSMA) imaging for standardized reporting.

    U.S. National Library of Medicine - Accessed 2026-09-03

    Scope: evidenceStudies, productFamilyContext, evidenceDiscovery

  14. Whole-body tumour burden on [18F]DCFPyL PET/CT in biochemical recurrence of prostate cancer: association with tumour biology and PSA kinetics.

    U.S. National Library of Medicine - Accessed 2026-09-03

    Scope: evidenceStudies, productFamilyContext, evidenceDiscovery

  15. Interval Changes in PSMA PET/CT During Radium-223 Therapy for Metastatic Bone Disease from Castration-Resistant Prostate Cancer.

    U.S. National Library of Medicine - Accessed 2026-09-03

    Scope: evidenceStudies, productFamilyContext, evidenceDiscovery

  16. Analytical performance validation of aPROMISE platform for prostate tumor burden, index and dominant tumor assessment with 18F-DCFPyL PET/CT. A pilot study.

    U.S. National Library of Medicine - Accessed 2026-09-03

    Scope: evidenceStudies, productFamilyContext, evidenceDiscovery

  17. Piflufolastat F 18 PET/CT in Patients With Suspected, or at High Risk for Metastatic ccRCC

    U.S. National Library of Medicine - Accessed 2026-09-03

    Scope: evidenceStudies, productFamilyContext, evidenceDiscovery

Research history

  1. K211655 FDA decision

    Regulatory record

    510(k)

  2. Source-review record updated

    Research record

    fda record reviewed

  3. Reader overview source-reviewed

    Editorial review

    Source-reviewed editorial overlay

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