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Lunar iDXA F1

by GE Medical Systems, Ultrasound & Primary Care Diagnostics, LLC

Ref H8930BF

Lunar iDXA F1 is a device classified as Class IIb in the EU and Class II in the US made by GE Medical Systems, Ultrasound & Primary Care Diagnostics, LLC, registered in EUDAMED on 1 Sep 2026 (Basic UDI-DI B-00840682117029), cleared under FDA 510(k) K191112 on 19 Sep 2019 (3 earlier submissions) and listed in FDA GUDID since 27 Jun 2016 (UDI-DI 00840682117029), active as of 25 Oct 2026. 4 FDA recalls are linked to it.

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

4 ongoing

This device is named in the recall

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K191112

+3 more

Trust

Unverified

Source EUDAMED, GUDID, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00840682117029 Basic UDI-DI 00840682117029UDI-DIDate1 Sep 2026RegisteredStatusActive
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK191112 Date19 Sep 2019DecidedStatusActive
United StatesGUDID listing GUDID Number00840682117029 UDI-DI Date27 Jun 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-00840682117029 registered 1 Sep 2026 Active
  • FDA 510(k) K191112 decided 19 Sep 2019 Active· +3 more in the status table
  • FDA GUDID UDI-DI 00840682117029 listed 27 Jun 2016 Listed

Recalls

4 recalls · 4 ongoing · FDA

  • 4 recalls, same reason

    • Ongoing Z-1712-2020 FDA Class II initiated 3 Dec 2019
    • Ongoing Z-1709-2020 FDA Class II initiated 3 Dec 2019
    • Ongoing Z-1711-2020 FDA Class II initiated 3 Dec 2019
    • Ongoing Z-1710-2020 FDA Class II initiated 3 Dec 2019

    An issue with the Lunar iDXA control panel may cause the start button to not release and potentially contribute to an accidental radiation occurrence.

Timeline

10 dated events

  1. Cleared FDA 510(k) K052581
  2. Cleared FDA 510(k) K133664
  3. Listed FDA GUDID 00840682117029
  4. Cleared FDA 510(k) K161682
  5. Cleared FDA 510(k) K191112
  6. Recall initiated FDA recalls Z-1712-2020
  7. Recall initiated FDA recalls Z-1709-2020
  8. Recall initiated FDA recalls Z-1711-2020
  9. Recall initiated FDA recalls Z-1710-2020
  10. Registered EUDAMED B-00840682117029

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
Lunar iDXA
Generic name
Bone absorptiometric x-ray system, dual-energy
Model / reference
H8930BF EUDAMED
F1 GUDID
Primary DI / UDI-DI
00840682117029
Basic UDI-DI
B-00840682117029
510(k) Number
FDA product code
KGI
EMDN code
Z11900103 X–ray bone densitometers
GMDN term
Bone absorptiometric x-ray system, dual-energy
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
892.1170
EU registration type
Legacy device (under a directive)
EU market of registration
Finland
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
H8930BF
GUDID
F1
Device classEUDAMED
Class IIb
GUDID
Class II

Device class is stated on each registry's own scale: Class IIb 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: Bone absorptiometric x-ray system, dual-energy

Cleared under the same submission (K133664)

Cleared under the same submission (K161682)

Similar devices

Also classified as Bone absorptiometric x-ray system, dual-energy.

Similar devices in this category

Other devices filed under BONE DENSITOMETRY SYSTEMS.

Other devices from GE Medical Systems, Ultrasound & Primary Care Diagnostics, LLC

See all devices from GE Medical Systems, Ultrasound & Primary Care Diagnostics, LLC →

Properties

  • Measuring function
  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (19, all answered No)