Radiology AI Directory

FDA-cleared profile

SubtleSYNTH (1.x)

Subtle Medical, Inc.

Authorized purpose: SubtleSYNTH is a software medical device consisting of a machine-learning algorithm that synthesizes a SynthSTIR contrast image from T1-weighted and T2-weighted spine MR images.

MSK and bone
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: SubtleSYNTH is a software medical device consisting of a machine-learning algorithm that synthesizes a SynthSTIR contrast image from T1-weighted and T2-weighted spine MR images.

Overview status: Source-reviewed overview

Clinical takeaway

Clinical role: SubtleSYNTH is a software medical device consisting of a machine-learning algorithm that synthesizes a SynthSTIR contrast image from T1-weighted and T2-weighted spine MR images.

Evidence takeaway

Evidence from the reviewed source record: The exact FDA 510(k) decision material for K241329 identifies SubtleSYNTH (1.x) and describes the indicated use summarized in this dossier. It is regulatory evidence for the exact submission, not independent clinical validation. No performance or outcome claim is promoted without exact product and version linkage.

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
SubtleSYNTH is a software medical device consisting of a machine-learning algorithm that synthesizes a SynthSTIR contrast image from T1-weighted and T2-weighted spine MR images.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Intended users
Qualified healthcare professionals trained for the exact represented anatomy, modality, and workflow.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Care setting and population
Hospital, clinic, imaging-center, procedural, dental, or other labeled clinical environments.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Workflow role
Medical-image processing, segmentation, enhancement, measurement, quantification, visualization, or reporting support under professional review.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Required input
Supported medical images, DICOM metadata, patient and protocol information, and release-specific user inputs.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Output and human action
Images, segmentations, measurements, models, calculations, overlays, or reports that require professional review.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Limitations
The synthesized image is dependent on the exact input sequences, scanner, patient, anatomy, and released software. It must be reviewed with the source images and does not establish universal diagnostic performance or clinical outcomes.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04

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
K241329
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Modality
MRI
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Anatomy
Spine
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Clearance type
510(k)
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Decision date
2024-07-11
  • 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
Standards-based DICOM/PACS integration was identified in the FDA submission materials; compatibility with a specific PACS, RIS, EHR, or orchestrator requires confirmation.
  • Public source
  • Exact FDA submission
  • Checked 2026-08-13

Normalized from the prior exact-submission review. Confirm interface versions and local compatibility during technical evaluation.

Deployment and data flow
Not established in reviewed sources
  • Reviewed sources checked
  • Exact FDA submission
  • Checked 2026-09-04

The exact FDA decision material does not establish the complete deployment topology, hosting responsibility, availability, upgrade path, or service contract.

Security and privacy
Not established in reviewed sources
  • Reviewed sources checked
  • Exact FDA submission
  • Checked 2026-09-04

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 healthcare professionals trained for the exact represented anatomy, modality, and workflow should operate or interpret this product. Local onboarding should cover the exact release, supported population, limitations, failure examples, escalation, downtime, and competency documentation.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Monitoring and change control
Monitor by exact hardware, software, model, algorithm, reconstruction, or configuration 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 synthesized image is dependent on the exact input sequences, scanner, patient, anatomy, and released software. It must be reviewed with the source images and does not establish universal diagnostic performance or clinical outcomes.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04

Release and scope verification

Map installed model, build, options, population, anatomy, inputs, outputs, and enabled functions to K241329 before acceptance. Later family features are not evidence for this exact submission.

exact submission · checked 2026-09-04
Source

Interoperability acceptance

The exact FDA material does not establish a complete interoperability contract. Establish and test supported input, output, identity, routing, archive, and downtime behavior locally.

exact submission · checked 2026-09-04
Source

Deployment and security qualification

The exact FDA material does not establish hosting, deployment topology, availability, upgrade path, or service responsibility. Obtain site-specific evidence before procurement.

exact submission · checked 2026-09-04
Source

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. The synthesized image is dependent on the exact input sequences, scanner, patient, anatomy, and released software. It must be reviewed with the source images and does not establish universal diagnostic performance or clinical outcomes.

exact submission · checked 2026-09-04

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. No exact-product price was found.

product family · checked 2026-09-04
Source

Lifecycle monitoring

Monitor by exact hardware, software, model, algorithm, reconstruction, or configuration 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 synthesized image is dependent on the exact input sequences, scanner, patient, anatomy, and released software. It must be reviewed with the source images and does not establish universal diagnostic performance or clinical outcomes.

exact submission · checked 2026-09-04

Revalidate after material software, hardware, model, protocol, interface, or clinical-policy changes.

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
The exact FDA 510(k) decision material for K241329 identifies SubtleSYNTH (1.x) and describes the indicated use summarized in this dossier. It is regulatory evidence for the exact submission, not independent clinical validation. No performance or outcome claim is promoted without exact product and version linkage.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Reported sensitivity
Not applicable
  • Not applicable
  • Not applicable
  • Checked 2026-09-04

Sensitivity is not a product-wide endpoint for this system or software function. Compare only an exact endpoint, threshold, population, version, and source if later verified.

Reported specificity
Not applicable
  • Not applicable
  • Not applicable
  • Checked 2026-09-04

Specificity is not a product-wide endpoint for this system or software function. Compare only an exact endpoint, threshold, population, version, and source if later verified.

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

K241329 FDA decision evidence for SubtleSYNTH (1.x)

  • DesignFDA 510(k) substantial-equivalence review of the exact submission, device description, indications, and verification or validation documentation.
  • PopulationSpine
  • Scopeexact submission
  • Tested versionSubtleSYNTH (1.x)
  • IndependenceSponsor or vendor study

K241329

The FDA decision material is manufacturer-submitted regulatory evidence. It is not independent clinical validation, and local technical, clinical, privacy, security, and workflow acceptance remains necessary.

Source

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 2026-09-04

No public list price for the exact cleared or approved 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, surgical, or diagnostic service line and verify payer, site-of-service, and coding assumptions independently.
  • Public source
  • Not applicable
  • Checked 2026-09-04

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 K241329 by exact native submission identifier. This does not exclude product-family, later, or adverse-event information.
  • Public source
  • Exact FDA submission
  • Checked 2026-09-04

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.

Human reviewedStatus
2026-09-20Last searched
33Fields reviewed
12Source classes checked
0Screened PubMed leads
0Screened trial leads
0Unreviewed FDA recall leads

The refreshed discovery snapshot contains no PubMed or ClinicalTrials.gov candidates; no external evidence was promoted. The current discovery snapshot contains 0 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, fda decision material, peer reviewed literature, clinical trial registry, reimbursement policy, fda device recall, 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 510(k) decision material K241329: SubtleSYNTH (1.x)

    U.S. Food and Drug Administration - Published 2024-07-11 - Accessed 2026-09-04

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

  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

Research history

  1. K241329 FDA decision

    Regulatory record

    510(k)

  2. Source-review record updated

    Research record

    human reviewed

  3. Reader overview source-reviewed

    Editorial review

    Source-reviewed editorial overlay

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