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Discovery MI

by GE Medical Systems, L.L.C.

Ref PCM-PET0009Model Discovery MI Gen2

Discovery MI is a device classified as Class IIb in the EU and Class II in the US made by GE Medical Systems, L.L.C., registered in EUDAMED on 7 Jan 2025 (Basic UDI-DI 8406821BUG00159HJ), cleared under FDA 510(k) K211846 on 20 Aug 2021 (1 earlier submission) and listed in FDA GUDID since 20 Oct 2020 (UDI-DI 00195278098603), active as of 25 Oct 2026. 3 FDA recalls are linked to it.

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

1 ongoing

This device is named in the recall

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K211846

+1 more

Trust

Unverified

Source EUDAMED, GUDID, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number8406821BUG00159HJ Basic UDI-DI 00195278098603UDI-DIDate7 Jan 2025RegisteredStatusActive
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK211846 Date20 Aug 2021DecidedStatusActive
United StatesGUDID listing GUDID Number00195278098603 UDI-DI Date20 Oct 2020ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 8406821BUG00159HJ registered 7 Jan 2025 Active
  • FDA 510(k) K211846 decided 20 Aug 2021 Active· +1 more in the status table
  • FDA GUDID UDI-DI 00195278098603 listed 20 Oct 2020 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

7 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 00195278098603
  6. Cleared FDA 510(k) K211846
  7. Registered EUDAMED 8406821BUG00159HJ

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
Discovery MI Gen2 EUDAMED
Discovery GUDID
Generic name
Full-body CT system
Model / reference
Discovery MI Gen2 EUDAMED
PCM-PET0009 EUDAMED
MI GUDID
Primary DI / UDI-DI
00195278098603
Basic UDI-DI
8406821BUG00159HJ
510(k) Number
FDA product code
JAK, KPS
EMDN code
Z11020301 CT/pet systems
GMDN term
Full-body CT system
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
892.1750, 892.1200
System or procedure pack
System which is a device in itself
EU registration type
Standard device
EU market of registration
France
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
Discovery MI Gen2
PCM-PET0009
GUDID
MI
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: Full-body CT systemPET system

Cleared under the same submission (K161574)

Similar devices in this category

Other devices filed under CT/PET SYSTEMS.

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Properties

  • Measuring function
  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (21, all answered No)