Skip to content

6Sc-D

by GE Healthcare Japan Corporation

Ref H46462LSModel 5890308

6Sc-D (H46462LS) is an extracorporeal ultrasound imaging transducer (EU MDR Class IIa; FDA Class II) made by GE Healthcare Japan Corporation, cleared under FDA 510(k) K251169 on 10 Jul 2025, registered in EUDAMED on 17 Jun 2025 (Basic UDI-DI 08406821BUG004827G) and listed in FDA GUDID since 15 Oct 2025 (UDI-DI 00195278723963), active as of 23 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 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K251169

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number00195278723963 UDI-DI Date15 Oct 2025ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK251169 Date10 Jul 2025DecidedStatusActive
European UnionCE/MDR EUDAMED Number08406821BUG004827G Basic UDI-DI 00195278723963UDI-DIDate17 Jun 2025RegisteredStatusActive

Official records

Across registries

3 registries list this device

  • FDA 510(k) K251169 decided 10 Jul 2025 Active
  • EUDAMED Basic UDI-DI 08406821BUG004827G registered 17 Jun 2025 Active
  • FDA GUDID UDI-DI 00195278723963 listed 15 Oct 2025 Listed

Timeline

3 dated events

  1. Registered EUDAMED 08406821BUG004827G
  2. Cleared FDA 510(k) K251169
  3. Listed FDA GUDID 00195278723963

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  • Withdrawn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 / Ref / Catalog
5890308, H46462LS, 6Sc-D
Primary DI / UDI-DI
00195278723963
Basic UDI-DI
08406821BUG004827G
Direct marketing DI
00195278723963
510(k) Number
FDA product code
IYN, ITX, IYO
EMDN code
Z110402010301 Transcutaneous ultrasound sector probes (phased array), two–dimensional
GMDN term
Extracorporeal ultrasound imaging transducer, hand-held
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
892.1550, 892.1570, 892.1560
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
5890308
H46462LS
GUDID
6Sc-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
JP-MF-000009291
Authorised representative
GE Medical Systems SCS FR-AR-000000344

Similar devices in this category

Other devices filed under TRANSCUTANEOUS ULTRASOUND SECTOR PROBES (PHASED ARRAY), TWO–DIMENSIONAL.

Other devices from GE Healthcare Japan Corporation

See all devices from GE Healthcare Japan Corporation →

Properties

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