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IB Lab LAMA V1.06

by IB Lab GmbH

Ref V1.06

IB Lab LAMA V1.06 is a device classified as Class I in the EU and Class II in the US made by IB Lab GmbH, registered in EUDAMED on 25 Sep 2026 (Basic UDI-DI B-09120105730570), cleared under FDA 510(k) K223646 on 16 Jun 2023 and listed in FDA GUDID since 12 Aug 2024 (UDI-DI 09120105730570), active as of 23 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDD 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K223646

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-09120105730570 Basic UDI-DI 09120105730570UDI-DIDate25 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number09120105730570 UDI-DI Date12 Aug 2024ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) GUDID from GUDID NumberK223646 Date16 Jun 2023IssuedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-09120105730570 registered 25 Sep 2026 Active
  • FDA 510(k) K223646 decided 16 Jun 2023 Active
  • FDA GUDID UDI-DI 09120105730570 listed 12 Aug 2024 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K223646
  2. Listed FDA GUDID 09120105730570
  3. Registered EUDAMED B-09120105730570

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Panda EUDAMED
IB Lab LAMA GUDID
Generic name
X-ray image interpretive software
Model / reference
V1.06
Primary DI / UDI-DI
09120105730570 EUDAMED
09120105730730 GUDID
Basic UDI-DI
B-09120105730570
510(k) Number
FDA product code
QIH
EMDN code
Z11069092 Various digital bioimaging management instruments - medical device software
GMDN term
X-ray image interpretive software
Device class
Class I EUDAMED
Class II GUDID
Regulation number
892.2050
EU registration type
Legacy device (under a directive)
EU market of registration
Austria
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
09120105730570
GUDID
09120105730730
Device classEUDAMED
Class I
GUDID
Class II

The registries describe this device under different primary UDI-DIs (EUDAMED lists 09120105730570; FDA GUDID lists 09120105730730), so their flags are not compared. Device class is stated on each registry's own scale: Class I in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: X-ray image interpretive software

Similar devices in this category

Other devices filed under VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE.

Other devices from IB Lab GmbH

See all devices from IB Lab GmbH →

Properties

  • Prescription use
  • Expiration date
Other properties (21, all answered No)