FDA-cleared profile
Subtle Medical, Inc.
SubtlePET is DICOM image-processing software that reduces noise in FDG, amyloid, 18F-DOPA, 18F-DCFPyL, Ga-68 Dotatate, and Ga-68 PSMA PET images for radiologist or nuclear-medicine-physician review.
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 K211964; confirm the exact cleared version, enabled options, deployment, and local compatibility.
Current vendor materials are product-family evidence for K211964; 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 K211964; 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 K211964 before acceptance.
exact submission · checked 2026-09-03Later product-family features are not evidence that this cleared release includes them.
K211964 describes a DICOM 3.0 receive-process-forward workflow. The current Subtle Medical conformance material is family context; validate node configuration, identifiers, supported transfer syntaxes, routing, and rollback for the installed release.
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. The cleared tracer, reconstruction input, scanner, acquisition, dose, noise level, and quantitative use determine applicability; image-processing benefit is not a universal diagnostic-performance claim.
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: The cleared tracer, reconstruction input, scanner, acquisition, dose, noise level, and quantitative use determine applicability; image-processing benefit is not a universal diagnostic-performance claim.
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 software, image-quality, DICOM, and functional validation · Supported PET images using the labeled radiotracers and DICOM node workflow
exact submission · Tested version: SubtlePET · Sponsor or vendor studyK211964
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 · Multi-region 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 established42323220
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 · Multi-region 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 established35543894
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 · Multi-region 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 established37231229
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 10 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 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.
Alternatives
Siemens Healthineers AG
BIOGRAPH One with syngo MR XB10 combines metabolic or physiologic PET information with MR anatomy, MR-based attenuation correction, fused alignment, and support for treatment...
Spectrum Dynamics Medical, Ltd.
VERITON CT 300/400 Series combines SPECT and CT for detection, localization, diagnosis, staging, restaging, organ-function assessment, therapy planning, guidance, and monitoring....
Hermes Medical Solutions AB
Voxel Dosimetry 3.1 calculates voxel-level absorbed-dose maps from nuclear-medicine images acquired after administration of FDA-approved therapeutic radiopharmaceuticals and...
Siemens Medical Solutions USA, Inc.
syngo.via MI Workflows, Scenium, and syngo MBF provide PET, SPECT, nuclear-medicine, CT, and MR viewing, manipulation, quantification, longitudinal comparison, and analysis for...