Release and scope verification
Map installed build, options, population, anatomy, inputs, outputs, and enabled functions to K182336.
exact submission · checked 2026-09-04FDA-cleared profile
SubtlePET
Subtle Medical, Inc.
SubtlePET V1.0.0 is image-processing software for transfer, storage, and noise reduction of FDG and amyloid PET images, including PET/CT and PET/MR studies.
Evidence status: each field shows source quality, applicability, and review date. Research pending, information not established in reviewed sources, and vendor documentation pending are distinct outcomes.
Clinical fit
What this tool is for
Start with the authorized purpose, then verify how it fits your service line and reading workflow.
- Exact purpose
- SubtlePET V1.0.0 is image-processing software for transfer, storage, and noise reduction of FDG and amyloid PET images, including PET/CT and PET/MR studies.
- Intended users
- Radiologists and nuclear medicine physicians.
- Care setting and population
- Radiology and nuclear medicine departments.
- Workflow role
- DICOM image transfer, storage, and noise-reduction preprocessing before professional interpretation.
- Required input
- DICOM 3.0 FDG and amyloid PET studies, including PET/CT and PET/MR datasets.
- Output and human action
- Enhanced PET studies with noise reduction forwarded to a destination such as PACS or a workstation.
- Limitations
- The FDA labeling describes image enhancement and noise reduction, not an autonomous diagnosis or treatment decision. Supported tracer, acquisition, reconstruction, and image-review boundaries remain applicable.
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.
Implementation
Questions for IT, informatics, and operations
Use these fields to structure a vendor demo, security review, and implementation estimate.
- Integration
- The FDA package describes a DICOM node receiving studies from a modality or other DICOM source, processing them, and forwarding the enhanced study to a destination.
- Deployment and data flow
- On-cloud
Deployment category preserved from the prior exact-submission review; hosting region, data flow, and current commercial configuration still require vendor confirmation.
- Security and privacy
- Not established in reviewed sources
Public materials reviewed for this exact submission 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
- Use by radiologists and nuclear medicine physicians. Follow the exact labeling, local training, supervision, and escalation requirements.
- Monitoring and change control
- Monitor labeled population, acquisition quality, exclusions, reviewer overrides, failures, and downstream workflow effects for K182336.
Deployment boundary
The exact public deployment boundary is incomplete; confirm hosting, data flow, availability, upgrades, security, service, and downtime locally.
exact submission · checked 2026-09-04Interoperability acceptance
The FDA package describes a DICOM node receiving studies from a modality or other DICOM source, processing them, and forwarding the enhanced study to a destination.
exact submission · checked 2026-09-04Clinical acceptance
Test labeled population, acquisition quality, exclusions, failed inputs, reviewer overrides, and downstream effects for K182336.
exact submission · checked 2026-09-04Economic evaluation
Exact-product price, implementation cost, reimbursement, and total-cost evidence remain to be obtained; do not infer them from FDA clearance.
product family · checked 2026-09-04Lifecycle monitoring
Monitor labeling, software version, complaints, recalls, failed inputs, overrides, and postmarket signals against the exact submission and installed configuration.
exact submission · checked 2026-09-04Evidence
Performance evidence
Metrics are shown only when they are tied to a source, endpoint, population, and tested product version.
- Evidence summary
- K182336 FDA decision material establishes the labeled use, workflow, inputs, outputs, and limitations for SubtlePET V1.0.0. No exact-submission clinical performance metric is promoted without a complete source table and version-scoped endpoint.
- Reported sensitivity
- Not applicable
Do not generalize an endpoint across populations, thresholds, versions, or workflows; use only exact evidence.metrics records.
- Reported specificity
- Not applicable
Do not generalize an endpoint across populations, thresholds, versions, or workflows; use only exact evidence.metrics records.
No contextualized exact-version metric has completed evidence review. Regulatory-document values, when available, are shown above with their limitations.
K182336 FDA evidence package for SubtlePET
FDA 510(k) decision evidence and product verification for the exact submission. · Whole-body and brain PET imaging regions, including FDG and amyloid PET studies
exact submission · Tested version: SubtlePET V1.0.0 · Sponsor or vendor studyK182336
FDA-submitted evidence for the exact decision; it is not independent clinical validation and does not establish local production qualification.
Economics and lifecycle
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
No public list price or commercial contract for the exact submission and version was identified.
- Reimbursement and coding
- Not established in reviewed sources
No exact-product payer coverage or reimbursement determination was identified in reviewed public material.
No product-specific code
No exact-product reimbursement determination identified in reviewed public material
Centers for Medicare & Medicaid Services · United StatesThis public-policy review is not a coverage determination. Verify payer, site-of-service, coding, and local value assumptions independently.
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
- No record matched K182336 by exact native submission identifier in the 2026-09-02 openFDA snapshot; this does not exclude product-family, later-version, or adverse-event information.
Buyer worksheet
Open questions to take to the vendor
- Verify security and privacy controls: Public materials reviewed for this exact submission do not establish the complete security posture. Request data-flow, identity, audit, encryption, retention, remote-access, vulnerability-management, backup, and incident-response evidence.
- Verify pricing and total cost: No public list price or commercial contract for the exact submission and version was identified.
- Verify reimbursement and coding relevance: No exact-product payer coverage or reimbursement determination was identified in reviewed public material.
Research record
What has been checked
This audit distinguishes completed source review from fields that have not yet been researched.
Human reviewedStatus
2026-09-04Last searched
27Fields reviewed
11Source classes checked
10Reviewed PubMed leads
0Reviewed trial leads
0Unreviewed FDA recall leads
No evidence was promoted. The records name SubtlePET or PET denoising but do not identify SubtlePET V1.0.0 or K182336; several use additional tracers or unmapped SP1 and SP2 variants outside exact version linkage. The current discovery snapshot contains 10 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, fda decision summary, acr ai central product, fda decision material, peer reviewed literature, clinical trial registry, reimbursement policy, fda device recall, pubmed, clinical trials, openfda device recall
Sources
Source ledger
Sources accessed through 2026-09-04.
- FDA 510(k) decision material K182336: SubtlePET U.S. Food and Drug Administration · 2026-09-04
- Artificial Intelligence-Enabled Medical Devices U.S. Food and Drug Administration · 2026-08-31
- SubtlePET model card (K182336) American College of Radiology · 2026-09-01
- PubMed biomedical literature index U.S. National Library of Medicine · 2026-09-01
- ClinicalTrials.gov study registry U.S. National Library of Medicine · 2026-09-01
- Medicare Coverage Database Centers for Medicare & Medicaid Services · 2026-09-01
- openFDA Device Recall API U.S. Food and Drug Administration · 2026-09-02
Alternatives
Related tools to compare
FDA-cleared K254013
SubtleHD-PET (1.x)
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.
- Modality
- PET/SPECT/Nuclear Medicine
- Anatomy
- Whole body and the body regions represented in PET studies
- Decision
- 2026-05-14
FDA-cleared K260524
uMI Panvivo (uMI Panvivo LS); uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S); uMI Panvivo (uMI Panvivo EX); uMI Panvivo (uMI Panvivo ES)
Shanghai United Imaging Healthcare Co., Ltd.
uMI Panvivo variants acquire and display PET and CT information for anatomical and functional imaging, radiopharmaceutical distribution, attenuation correction, and the labeled...
- Modality
- PET/SPECT/Nuclear Medicine
- Anatomy
- Whole body; brain; head and neck; heart; lung; breast; gastrointestinal; urinary; genital; and musculoskeletal anatomy
- Decision
- 2026-04-03
FDA-cleared K253564
uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S); uMI Panvivo (uMI Panvivo EX); uMI Panvivo (uMI Panvivo ES)
Shanghai United Imaging Healthcare Co., Ltd.
uMI Panvivo PET/CT acquires anatomical CT and functional PET images of radiopharmaceutical distribution for qualified diagnostic and treatment-planning workflows, including...
- Modality
- PET/SPECT/Nuclear Medicine
- Anatomy
- Whole body, head and neck, cardiac, and other labeled PET/CT regions
- Decision
- 2026-02-13
FDA-cleared K253023
BIOGRAPH One
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...
- Modality
- PET/SPECT/Nuclear Medicine
- Anatomy
- Multi-region
- Decision
- 2026-01-15