Synapse PACS (7.6.0)

Evidence summary

Vendor documentation pending

Vendor confirmation Exact FDA submission Checked 2026-09-05

The accessible extracted summary establishes identity and intended use. A complete performance abstraction and release-specific clinical validation were not established; the knee-template paper candidate does not validate PACS 7.6.0.

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

Postmarket safety review

Not established in reviewed sources

Reviewed sources checked Exact FDA submission Checked 2026-09-04

No native submission-identifier match was found in the checked openFDA radiology recall snapshot. Product-name, manufacturer, and adverse-event searches remain necessary; this does not establish that no recall or safety report exists.

• Verify anatomy and target condition: The extracted FDA intended-use text describes general medical-image management without an exhaustive anatomy list. The catalog N/A placeholder is retained in the correction sidecar; it is not an exclusion of anatomical applications.
• Verify care setting and population: Enterprise medical-image use is described, but an exhaustive setting and age eligibility statement was not established in the extracted summary text.
• Verify security and privacy controls: No dated, scoped security attestation for this installed release and hosting arrangement was reviewed. Hosting region, PHI flow, retention, access controls, audit logging, and incident response remain to be confirmed.
• Verify training: Role-specific onboarding, mammography display training, and support commitments were not established for 7.6.0.
• Verify pricing and total cost: The reviewed vendor product page provides no scoped 7.6.0 price. Obtain licensing unit, storage and migration charges, implementation, support, term, and optional-module costs; public procurement research is incomplete.
• Verify reimbursement and coding relevance: No applicable payer policy was reviewed. No product-specific code, coverage, or payment conclusion is made.
• Verify exact-version clinical evidence: The accessible extracted summary establishes identity and intended use. A complete performance abstraction and release-specific clinical validation were not established; the knee-template paper candidate does not validate PACS 7.6.0.
• Verify local validation and lifecycle monitoring: Release update control, local acceptance, downtime procedures, and incident escalation require a current vendor and site plan.
• Verify recalls and postmarket safety signals: No native submission-identifier match was found in the checked openFDA radiology recall snapshot. Product-name, manufacturer, and adverse-event searches remain necessary; this does not establish that no recall or safety report exists.

Stored metadata screened. PMID 36224662 is a 2022 knee-arthroplasty template simulation study, not validation of the 2026 PACS 7.6.0 submission; not promoted. No stored trial candidates. Full text of that paper was not reviewed. The current discovery snapshot contains 1 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 material, vendor product page, literature index, trial registry, fda device recall, pubmed, clinical trials, openfda device recall

• FDA 510(k) K261713: Synapse PACS (7.6.0) U.S. Food and Drug Administration · 2026-09-05
• Artificial Intelligence-Enabled Medical Devices U.S. Food and Drug Administration · 2026-08-31
• 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
• openFDA Device Recall API U.S. Food and Drug Administration · 2026-09-02
• Synapse Radiology PACS product page FUJIFILM Healthcare Americas Corporation · 2026-09-05