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Prodigy F2

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

Ref H8930CAModel Full

Prodigy F2 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-00840682138345), cleared under FDA 510(k) K191112 on 19 Sep 2019 (3 earlier submissions) and listed in FDA GUDID since 3 Jul 2018 (UDI-DI 00840682138345), active as of 23 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

3 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 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00840682138345 Basic UDI-DI 00840682138345UDI-DIDate1 Sep 2026RegisteredStatusActive
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK191112 Date19 Sep 2019DecidedStatusActive
United StatesGUDID listing GUDID Number00840682138345 UDI-DI Date3 Jul 2018ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-00840682138345 registered 1 Sep 2026 Active
  • FDA 510(k) K191112 decided 19 Sep 2019 Active· +3 more in the status table
  • FDA GUDID UDI-DI 00840682138345 listed 3 Jul 2018 Listed

Recalls

4 recalls · 3 ongoing · FDA

  • 3 recalls, same reason

    • Ongoing Z-1712-2020 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.

    • Terminated Z-1395-2018 FDA Class II initiated 16 Mar 2018

    Under certain conditions, when using DICOM Worklist along with DICOM MPPS, a report for a bone density exam may be sent to PACS with the incorrect patient information in the DICOM header. The correct patient information will be listed on the DICOM report image; however, the report may appear under a different patients name in the PACS.

Timeline

10 dated events

  1. Cleared FDA 510(k) K982267
  2. Cleared FDA 510(k) K133664
  3. Cleared FDA 510(k) K161682
  4. Recall initiated FDA recalls Z-1395-2018
  5. Listed FDA GUDID 00840682138345
  6. Cleared FDA 510(k) K191112
  7. Recall initiated FDA recalls Z-1712-2020
  8. Recall initiated FDA recalls Z-1711-2020
  9. Recall initiated FDA recalls Z-1710-2020
  10. Registered EUDAMED B-00840682138345

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
Prodigy
Generic name
Bone absorptiometric x-ray system, dual-energy
Model / reference
Full EUDAMED
H8930CA EUDAMED
F2 GUDID
Primary DI / UDI-DI
00840682138345
Basic UDI-DI
B-00840682138345
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
Full
H8930CA
GUDID
F2
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)