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Lunit INSIGHT DBT

by Lunit Inc. 2 variants

Ref 126012

Lunit INSIGHT DBT (126012) is a X-ray image interpretive software (EU MDR Class IIa; FDA Class II; FDA product code QDQ) made by Lunit Inc., cleared under FDA 510(k) K253796 on 26 Mar 2026 (1 earlier submission), registered in EUDAMED on 1 Dec 2022 (Basic UDI-DI 88000760MMGXH) and listed in FDA GUDID since 1 Dec 2023 (UDI-DI 08800076000148), active as of 25 Oct 2026.

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

CE MDR 510(k)

Valid until

No date given

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

FDA recalls

None found

in data synced 25 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K253796

+1 more

Trust

Unverified

Source EUDAMED, FDA 510(k), GUDID, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK253796 Date26 Mar 2026DecidedStatusActive
United StatesGUDID listing GUDID Number08800076000148 UDI-DI Date1 Dec 2023ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) 510(k) NumberK231470 Date6 Nov 2023IssuedStatusActive
European UnionCE/MDR EUDAMED Number88000760MMGXH Basic UDI-DI Date1 Dec 2022RegisteredStatusActive

Official records

Across registries

3 registries list this device

  • FDA 510(k) K253796 decided 26 Mar 2026 Active· +1 more in the status table
  • EUDAMED Basic UDI-DI 88000760MMGXH registered 1 Dec 2022 Active
  • FDA GUDID UDI-DI 08800076000148 listed 1 Dec 2023 Listed

Timeline

4 dated events

  1. Registered EUDAMED 88000760MMGXH
  2. Cleared FDA 510(k) K231470
  3. Listed FDA GUDID 08800076000148
  4. Cleared FDA 510(k) K253796

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · 510(k) · GUDID

Generic name
X-ray image interpretive software
Device name
Lunit INSIGHT MMG
Model / reference
126012 EUDAMED
1.0 GUDID
1.2 GUDID
Primary DI / UDI-DI
08800076000148, 08800076000230
Basic UDI-DI
88000760MMGXH
510(k) Number
FDA product code
QDQ
EMDN code
Z11069092 Various digital bioimaging management instruments - medical device software
GMDN term
X-ray image interpretive software
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
892.2090
Special device type
Software
EU registration type
Standard device
EU market of registration
Germany
France
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
126012
GUDID
1.0
1.2
Device classEUDAMED
Class IIa
GUDID
Class II

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Manufacturer details

EUDAMED SRN
KR-MF-000005200
Authorised representative
Obelis s.a. BE-AR-000000106

Similar devices in this category

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

Other devices from Lunit Inc.

See all devices from Lunit Inc. →

Properties

  • Prescription use
  • Serial number
Other properties (23, all answered No)