FDA-cleared profile
Subtle Medical, Inc.
SubtleHD-PET 1.x is image-processing software that reduces PET or PET/CT/PET-MR image noise for images acquired with any radiotracer within the labeled workflow.
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.
Deployment details for the exact cleared configuration are not established in the public FDA decision material.
Security controls, hosting boundaries, audit behavior, identity management, and incident commitments for the exact configuration are not established in the public FDA decision material.
Post-deployment monitoring, drift thresholds, alerting, and revalidation commitments for the exact configuration require vendor and site confirmation.
Map the installed model, build, options, population, anatomy, inputs, outputs, and enabled functions to K254013 before acceptance.
exact submission · checked 2026-09-04Later product-family features are not evidence that this cleared release includes them.
Receives PET DICOM through a medical device data system and returns enhanced DICOM while retaining the original images.
exact submission · checked 2026-09-04Test representative identifiers, orientation, geometry, measurements, units, routing, failure handling, and round trips locally.
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. The software processes images and does not control the scanner; original and enhanced images must be distinguished, and clinical interpretation remains with the physician.
exact submission · checked 2026-09-04Define 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 2026-09-04No exact-product price was found in the evidence set; productivity or value claims require local evidence.
Revalidate after material software, hardware, model, protocol, interface, or clinical-policy changes; exact monitoring thresholds and vendor commitments are unknown.
exact submission · checked 2026-09-04Establish ownership for data quality, overrides, drift, incidents, recalls, and change control.
Evidence
Metrics are shown only when they are tied to a source, endpoint, population, and tested product version.
No exact-product, version-specific sensitivity endpoint was established for this submission in the evidence set.
No exact-product, version-specific specificity endpoint was established for this submission in the evidence set.
No contextualized exact-version metric has completed evidence review. Regulatory-document values, when available, are shown above with their limitations.
FDA submission-level decision material with device, software, performance, safety, and/or usability verification as applicable; not independent clinical validation. · Population and workflow are limited to the exact FDA labeling summarized for this submission.
exact submission · Tested version: Exact FDA submission release; version not separately stated in the public decision material · Sponsor or vendor studyK254013
Evidence submitted for the exact FDA decision is not independent clinical validation. Local technical, clinical, privacy, security, and workflow acceptance remains necessary.
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 in the evidence set. Obtain a written quote covering license or hardware basis, implementation, interfaces, infrastructure, training, service, upgrades, renewal, downtime, and exit costs.
No separate named-product payment identified in reviewed public material
Centers for Medicare & Medicaid Services · United StatesReviewed CMS material is not a product-specific price or coverage determination; do not infer reimbursement from FDA clearance.
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.
This submission was added after the prior exact-submission extraction and remains queued for source review. Exact FDA decision material was reviewed for identity and labeled use. Optional literature, trial, and recall candidates were not promoted without exact product or version applicability; commercial, security, and performance claims remain unknown where not established. Automated exact-name discovery found 0 PubMed and 0 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 material, peer reviewed literature, clinical trial registry, reimbursement policy, fda device recall, pubmed, clinical trials, openfda device recall
Sources
Sources accessed through 2026-09-04.
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