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Head Auto Views

by GE Medical Systems, LLC

Ref 5973666Model Head Auto Views

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

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None ongoing

2 closed

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number00195278932365 UDI-DI Date26 Jan 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number8406821BUG00411H5 Basic UDI-DI 00195278932365UDI-DIDate3 Jun 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

2 recalls · FDA

    • Terminated Z-0901-2013 FDA Class II initiated 25 May 2012

    Incorrect views and measurements possible. GE Healthcare became aware of multiple potential safety issues involving the Advantage workstation, Volume Viewer Plus and Volume Analysis.

    • Terminated Z-2312-2008 FDA Unclassified (pre-2012) initiated 1 May 2008

    GE Healthcare has recently became aware of a possible mismatch between the label of the tracked vessel and the underlying image associated with the cardio- vascular applications of the Advantage workstation that may impact patient safety.

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  • Withdrawn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

Generic Name
CT system application software
Model / Ref / Catalog
Head Auto Views, 5973666, 1.1
Primary DI / UDI-DI
00195278932365
Basic UDI-DI
8406821BUG00411H5
Direct Marketing DI
00195278932365
510(k) Number
FDA Product Code
JAK, LLZ, LNH
EMDN Code
Z11030692 Computed tomographs (CT) - medical device software
GMDN Term
CT system application software
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
892.1750, 892.2050, 892.1000
Special Device Type
Software
EU market of registration
Belgium
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
Head Auto Views
5973666
GUDID
1.1
Device ClassEUDAMED
Class IIa
GUDID
Class II

Manufacturer details

EUDAMED SRN
US-MF-000018315
Authorised representative
GE Medical Systems SCS FR-AR-000000344

Other devices from GE Medical Systems, LLC

See all devices from GE Medical Systems, LLC →

Properties

  • Prescription Use
  • Lot / Batch Number

Other properties (22)

  • 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
  • Measuring Function: 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
  • Manufacturing Date: No