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Infrascanner 2500

by Infrascan, 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 Number00861606000326 UDI-DI Date14 Jun 2023ListedStatusListed 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  • Withdrawn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
Infrascanner
Generic Name
Near-infrared intracranial haematoma detector
Model / Ref / Catalog
2500
Primary DI / UDI-DI
00861606000326
510(k) Number
FDA Product Code
OPT
GMDN Term
Near-infrared intracranial haematoma detector
Device Class
Class II
Regulation Number
882.1935
GUDID distribution status
In Commercial Distribution

Related devices

Category: Near-infrared intracranial haematoma detector

Similar devices

Also classified as Near-infrared intracranial haematoma detector.

Other devices from Infrascan, Inc.

See all devices from Infrascan, Inc. →

Properties

  • Lot / Batch Number
  • Manufacturing Date

Other properties (12)

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