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SwiftSight-Brain SS25-BR-CL

by AIRS Medical Inc.

SwiftSight-Brain SS25-BR-CL is a Class II device made by AIRS Medical Inc., cleared under FDA 510(k) K251483 on 23 Sep 2025 and listed in FDA GUDID since 30 Sep 2025 (UDI-DI 08800124700129), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

510(k) K251483

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number08800124700129 UDI-DI Date30 Sep 2025ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK251483 Date23 Sep 2025DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K251483 decided 23 Sep 2025 Active
  • FDA GUDID UDI-DI 08800124700129 listed 30 Sep 2025 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K251483
  2. Listed FDA GUDID 08800124700129

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
SwiftSight-Brain
Generic name
Radiology DICOM image processing application software
Model / reference
SS25-BR-CL
Primary DI / UDI-DI
08800124700129
510(k) Number
FDA product code
QIH, LLZ
GMDN term
Radiology DICOM image processing application software
Device class
Class II
Regulation number
892.2050
GUDID distribution status
In Commercial Distribution

Similar devices

Other devices filed under FDA product code QIH (Automated Radiological Image Processing Software).

Other devices from AIRS Medical Inc.

See all devices from AIRS Medical Inc. →

Properties

  • Prescription use
  • Lot / batch number
Other properties (13, all answered No)