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Spectral AI DeepView AI System

by Spectralmd, Inc.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00860009533615 UDI-DI Date17 Aug 2026ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Spectral AI
Generic Name
Wound management image-analysis software
Model / Ref / Catalog
DeepView AI System, 12001
Description
AI-Based Wound Assessment and Imaging System Additional Catalog Numbers: 12002
Primary DI / UDI-DI
00860009533615
De Novo Number
FDA Product Code
SHY
GMDN Term
Wound management image-analysis software
Device Class
Class II
Regulation Number
878.1840
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Unsafe

Other devices from Spectralmd, Inc.

Properties

  • Prescription Use
  • Serial Number
  • Manufacturing Date

Other properties (11)

  • 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
  • Lot / Batch Number: No
  • Expiration Date: No