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Koala V2.11

by IB Lab GmbH

Koala V2.11 is a Class II device made by IB Lab GmbH, cleared under FDA 510(k) K192109 on 5 Nov 2019 and listed in FDA GUDID since 11 Jan 2022 (UDI-DI 09120105730464), 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) K192109

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 Number09120105730464 UDI-DI Date11 Jan 2022ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK192109 Date5 Nov 2019DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K192109 decided 5 Nov 2019 Active
  • FDA GUDID UDI-DI 09120105730464 listed 11 Jan 2022 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K192109
  2. Listed FDA GUDID 09120105730464

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Koala
Generic name
X-ray image interpretive software
Model / reference
V2.11
Primary DI / UDI-DI
09120105730464
510(k) Number
FDA product code
LLZ, JAK
GMDN term
X-ray image interpretive software
Device class
Class II
Regulation number
892.2050, 892.1750
GUDID distribution status
In Commercial Distribution

Similar devices

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

Other devices from IB Lab GmbH

See all devices from IB Lab GmbH →

Properties

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