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Xeleris V Processing & Review System

by GE Medical Systems Israel, Functional Imaging 2 variants

Ref 6015087Model Xeleris V Processing and Review System

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number00198953246405 UDI-DI Date3 Aug 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number8406821BUG00344HF Basic UDI-DI 00198953246405UDI-DIDate20 May 2024RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Xeleris V Processing & Review System EUDAMED
Xeleris V Processing and Review System GUDID
Generic Name
Nuclear medicine system workstation
Model / Ref / Catalog
Xeleris V Processing and Review System, 6015087, 5.1
Primary DI / UDI-DI
00198953246405
Basic UDI-DI
8406821BUG00344HF
510(k) Number
FDA Product Code
LLZ
EMDN Code
Z11069092 Various digital bioimaging management instruments - medical device software
GMDN Term
Nuclear medicine system workstation
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
892.2050
EU market of registration
France
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
Xeleris V Processing and Review System
6015087
GUDID
5.1
Device ClassEUDAMED
Class IIa
GUDID
Class II

Manufacturer details

EUDAMED SRN
IL-MF-000003062
Authorised representative
GE Medical Systems SCS FR-AR-000000344

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Properties

  • Measuring Function
  • Prescription Use
  • Lot / Batch Number
  • Manufacturing Date

Other properties (20)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No