Skip to content

6VC-D

by GE Parallel Design, Inc.

Ref H44901AQ

6VC-D (H44901AQ) is a device classified as Class IIa in the EU and Class II in the US made by GE Parallel Design, Inc., registered in EUDAMED on 25 Apr 2023 (Basic UDI-DI 8406821BUG00387HZ), cleared under FDA 510(k) K200743 on 23 Jul 2020 and listed in FDA GUDID since 7 Aug 2020 (UDI-DI 00840682142366), active as of 22 Oct 2026.

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

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K200743

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number8406821BUG00387HZ Basic UDI-DI 00840682142366UDI-DIDate25 Apr 2023RegisteredStatusActive
United StatesGUDID listing GUDID Number00840682142366 UDI-DI Date7 Aug 2020ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK200743 Date23 Jul 2020DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 8406821BUG00387HZ registered 25 Apr 2023 Active
  • FDA 510(k) K200743 decided 23 Jul 2020 Active
  • FDA GUDID UDI-DI 00840682142366 listed 7 Aug 2020 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K200743
  2. Listed FDA GUDID 00840682142366
  3. Registered EUDAMED 8406821BUG00387HZ

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  • Withdrawn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

Generic name
Extracorporeal ultrasound imaging transducer, hand-held
Model / reference
H44901AQ EUDAMED
6Vc-D GUDID
Primary DI / UDI-DI
00840682142366
Basic UDI-DI
8406821BUG00387HZ
510(k) Number
FDA product code
IYO, IYN, ITX
EMDN code
Z110402010101 Two–dimensional linear–array transcutaneous ultrasound probes
GMDN term
Extracorporeal ultrasound imaging transducer, hand-held
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
892.1560, 892.1550, 892.1570
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
H44901AQ
GUDID
6Vc-D
Device classEUDAMED
Class IIa
GUDID
Class II

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Manufacturer details

EUDAMED SRN
US-MF-000009295
Authorised representative
GE Medical Systems SCS FR-AR-000000344

Related devices

Category: Extracorporeal ultrasound imaging transducer, hand-held

Similar devices in this category

Other devices filed under TWO–DIMENSIONAL LINEAR–ARRAY TRANSCUTANEOUS ULTRASOUND PROBES.

Other devices from GE Parallel Design, Inc.

  • 4C

    Class II

  • 8l-Rs Open recall

    Class II

  • 7S-Rs Open recall

    Class II

  • 4C-Rs Open recall

    Class II

See all devices from GE Parallel Design, Inc. →

Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (22, all answered No)