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Synapse Lung Nodule AI LUNG NODULE AI V1.0 SOFT

by Fujifilm Corporation

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number04547410491814 UDI-DI Date10 Sep 2026ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Synapse Lung Nodule AI
Generic Name
Basic x-ray clinical assessment support software
Model / Reference
LUNG NODULE AI V1.0 SOFT
Primary DI / UDI-DI
04547410491814
510(k) Number
FDA Product Code
OEB
GMDN Term
Basic x-ray clinical assessment support software
Device Class
Class II
Regulation Number
892.2050
GUDID distribution status
In Commercial Distribution

Other devices from Fujifilm Corporation

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Properties

  • Prescription Use
  • Lot / Batch Number

Other properties (12)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No