FDA-cleared profile
EXINI Diagnostics AB
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.
Clinical fit
Start with the authorized purpose, then verify how it fits your service line and reading workflow.
Regulatory identity
The FDA listing establishes the regulatory identity. It does not by itself establish local workflow fit, pricing, security, or performance in your environment.
Implementation
Use these fields to structure a vendor demo, security review, and implementation estimate.
Current vendor materials are product-family evidence for K211655; confirm the exact cleared version, enabled options, deployment, and local compatibility.
Current vendor materials are product-family evidence for K211655; confirm the exact cleared version, enabled options, deployment, and local compatibility.
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.
Current vendor materials are product-family evidence for K211655; confirm the exact cleared version, enabled options, deployment, and local compatibility.
Map the installed model, build, options, population, anatomy, inputs, outputs, and enabled AI functions to K211655 before acceptance.
exact submission · checked 2026-09-03Later product-family features are not evidence that this cleared release includes them.
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 2026-09-03Test 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.
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 2026-09-03Define stop-use, escalation, rollback, and revalidation triggers before production use.
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 2026-09-03No exact-product price was found in the reviewed public material; vendor productivity claims are scenario inputs, not guaranteed local savings.
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 2026-09-03Revalidate 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.
Evidence
Metrics are shown only when they are tied to a source, endpoint, population, and tested product version.
Sensitivity is not the primary endpoint for this system, reconstruction, segmentation, guidance, or quantitative function. Use the task-specific evidence below.
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.
Manufacturer phantom, analytical, predicate-comparison, and clinical performance validation · PSMA PET/CT examinations for prostate-cancer imaging, quantification, and structured reporting
exact submission · Tested version: aPROMISE · Sponsor or vendor studyK211655
Manufacturer evidence submitted for FDA clearance or approval; local clinical, technical, and workflow acceptance remains necessary.
Peer-reviewed literature candidate identified by exact-name search; full product and version applicability review pending · Prostate or related PET/SPECT/Nuclear Medicine workflow; exact product and version linkage not established
product family · Tested version: Candidate source; exact FDA submission and product version not established · Independence not established41101977
Candidate source was found by automated exact-name search; product or version linkage and clinical endpoint were not independently established, so it must not be treated as exact-submission performance evidence.
Peer-reviewed literature candidate identified by exact-name search; full product and version applicability review pending · Prostate or related PET/SPECT/Nuclear Medicine workflow; exact product and version linkage not established
product family · Tested version: Candidate source; exact FDA submission and product version not established · Independence not established40665093
Candidate source was found by automated exact-name search; product or version linkage and clinical endpoint were not independently established, so it must not be treated as exact-submission performance evidence.
Peer-reviewed literature candidate identified by exact-name search; full product and version applicability review pending · Prostate or related PET/SPECT/Nuclear Medicine workflow; exact product and version linkage not established
product family · Tested version: Candidate source; exact FDA submission and product version not established · Independence not established37009941
Candidate source was found by automated exact-name search; product or version linkage and clinical endpoint were not independently established, so it must not be treated as exact-submission performance evidence.
ClinicalTrials.gov candidate identified by exact-name search; full product and version applicability review pending · Prostate or related PET/SPECT/Nuclear Medicine workflow; exact product and version linkage not established
product family · Tested version: Candidate source; exact FDA submission and product version not established · Independence not establishedNCT07084909
Candidate source was found by automated exact-name search; product or version linkage and clinical endpoint were not independently established, so it must not be treated as exact-submission performance evidence.
Economics and lifecycle
These are common procurement questions; unknown values remain visible until a source supports them.
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.
No separate named-product payment identified in reviewed public material
Centers for Medicare & Medicaid Services · United StatesBuild a local total-cost and value model; do not infer reimbursement from FDA clearance or approval.
Safety and lifecycle
Recall and adverse-event records are shown only after product matching. Adverse-event reports do not establish incidence or causality.
Exact-identifier review does not prove absence of all product-family safety signals.
Buyer worksheet
Research record
This audit distinguishes completed source review from fields that have not yet been researched.
Recovered from the prior exact-submission extraction and normalized under the current provenance rules. Exact FDA decision materials were reviewed for identity, indication, users, workflow, limitations, and submitted performance. Current vendor material is labeled product-family context where it does not establish the exact release. PubMed and ClinicalTrials.gov results are retained as candidate evidence with version applicability pending; CMS reimbursement context and exact-identifier openFDA postmarket results were also checked. Pricing, final security architecture, contracted services, enabled options, and local interoperability remain organization-specific evidence. Automated exact-name discovery found 9 PubMed and 1 ClinicalTrials.gov candidate records. Candidates require human product and version matching; zero candidates is not evidence that no studies exist. Native FDA recall identifiers produced 0 postmarket candidate records; 0 have been reviewed (0 published, 0 rejected) and 0 remain unreviewed.
Candidate leads remain unpublished until a human confirms the exact product and tested version.
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, pubmed, clinical trials, openfda device recall
Sources
Sources accessed through 2026-09-03.
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