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Prodigy F1

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

Prodigy F1 is a Class II device made by GE Medical Systems, Ultrasound & Primary Care Diagnostics, LLC, cleared under FDA 510(k) K191112 on 19 Sep 2019 (3 earlier submissions) and listed in FDA GUDID since 27 Jun 2016 (UDI-DI 00840682117098), active as of 23 Oct 2026. 4 FDA recalls are linked to it.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

3 ongoing

This device is named in the recall

Documents

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK191112 Date19 Sep 2019DecidedStatusActive
United StatesGUDID listing Number00840682117098 UDI-DI Date27 Jun 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • FDA 510(k) K191112 decided 19 Sep 2019 Active· +3 more in the status table
  • FDA GUDID UDI-DI 00840682117098 listed 27 Jun 2016 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

9 dated events

  1. Cleared FDA 510(k) K982267
  2. Cleared FDA 510(k) K133664
  3. Listed FDA GUDID 00840682117098
  4. Cleared FDA 510(k) K161682
  5. Recall initiated FDA recalls Z-1395-2018
  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

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Prodigy
Generic name
Bone absorptiometric x-ray system, dual-energy
Model / reference
F1
Primary DI / UDI-DI
00840682117098
510(k) Number
FDA product code
KGI
GMDN term
Bone absorptiometric x-ray system, dual-energy
Device class
Class II
Regulation number
892.1170
GUDID distribution status
In Commercial Distribution

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

Other devices filed under FDA product code KGI (Densitometer, bone).

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

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

Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (12, all answered No)