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BRIT Lite 3.4.3

by Brit Systems

BRIT Lite 3.4.3 is a Class II device made by Brit Systems, cleared under FDA 510(k) K081168 on 23 Mar 2009 and listed in FDA GUDID since 20 Nov 2025 (UDI-DI 00850631008780), active as of 22 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 22 Oct 2026

Documents

510(k) K081168

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00850631008780 UDI-DI Date20 Nov 2025ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK081168 Date23 Mar 2009DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K081168 decided 23 Mar 2009 Active
  • FDA GUDID UDI-DI 00850631008780 listed 20 Nov 2025 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K081168
  2. Listed FDA GUDID 00850631008780

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
BRIT Lite
Generic name
Radiology DICOM image processing application software
Model / reference
3.4.3
Primary DI / UDI-DI
00850631008780
510(k) Number
FDA product code
LLZ
GMDN term
Radiology DICOM image processing application software
Device class
Class II
Regulation number
892.2050
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K081168)

and 5 more cleared under K081168

Similar devices

Other devices filed under FDA product code LLZ (System, Image Processing, Radiological).

Other devices from Brit Systems

See all devices from Brit Systems →

Properties

Other properties (15, all answered No)