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Discovery MI

by GE Medical Systems, L.L.C. 2 variants

Discovery MI is a Class II device made by GE Medical Systems, L.L.C., cleared under FDA 510(k) K161574 on 11 Aug 2016 and listed in FDA GUDID since 13 Mar 2019 (UDI-DI 00840682143523), active as of 23 Oct 2026. 3 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

1 ongoing

This device is named in the recall

Documents

510(k) K161574

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00840682143523 UDI-DI Date13 Mar 2019ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK161574 Date11 Aug 2016DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K161574 decided 11 Aug 2016 Active
  • FDA GUDID UDI-DI 00840682143523 listed 13 Mar 2019 Listed

Recalls

3 recalls · 1 ongoing · FDA

    • Ongoing Z-1749-2019 FDA Class II initiated 12 Feb 2019

    GE Healthcare PET/CT Table Stop Without Stopping X-Ray Exposure

    • Terminated Z-2580-2018 FDA Class II initiated 24 May 2018

    Some CT and CT/PET systems recently installed with a GE supplied A! electrical panel may not be properly wired to the partial system UPS (Uninteruptible Power Supply).

    • Terminated Z-2193-2017 FDA Class II initiated 19 May 2017

    It was discovered that an issue has been identified that can result in a scan starting before the prescribed delay has completed.

Timeline

5 dated events

  1. Cleared FDA 510(k) K161574
  2. Recall initiated FDA recalls Z-2193-2017
  3. Recall initiated FDA recalls Z-2580-2018
  4. Recall initiated FDA recalls Z-1749-2019
  5. Listed FDA GUDID 00840682143523

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Discovery
Generic name
PET system
Model / reference
MI
Primary DI / UDI-DI
00840682143523
510(k) Number
FDA product code
KPS, JAK
GMDN term
PET system
Device class
Class II
Regulation number
892.1200, 892.1750
GUDID distribution status
In Commercial Distribution

Related devices

Category: Full-body CT systemPET system

Cleared under the same submission (K161574)

Similar devices

Other devices filed under FDA product code KPS (System, tomography, computed, emission).

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See all devices from GE Medical Systems, L.L.C. →

Properties

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