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8C-Rs

by GE Healthcare Japan Corporation

Ref H40402LSModel 2354973

8C-Rs (H40402LS) is an extracorporeal ultrasound imaging transducer (EU MDR Class IIa; FDA Class II) made by GE Healthcare Japan Corporation, registered in EUDAMED on 6 Feb 2026 (Basic UDI-DI 8406821BUG00225H6), cleared under FDA 510(k) K160184 on 25 Feb 2016 and listed in FDA GUDID since 15 Jul 2016 (UDI-DI 00840682106962), active as of 22 Oct 2026. One FDA recall is 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) K160184

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 Number8406821BUG00225H6 Basic UDI-DI 00840682106962UDI-DIDate6 Feb 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00840682106962 UDI-DI Date15 Jul 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) GUDID from GUDID NumberK160184 Date25 Feb 2016IssuedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 8406821BUG00225H6 registered 6 Feb 2026 Active
  • FDA 510(k) K160184 decided 25 Feb 2016 Active
  • FDA GUDID UDI-DI 00840682106962 listed 15 Jul 2016 Listed

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-0865-2024 FDA Class II initiated 22 Dec 2023

    GE HealthCare has become aware of an issue with certain IC9-RS ultrasound probes (see Affected Products List) that can result in a double image artifact creating a ghost image with realistic features. An unrecognized artifact may lead to misdiagnosis.

Timeline

4 dated events

  1. Cleared FDA 510(k) K160184
  2. Listed FDA GUDID 00840682106962
  3. Recall initiated FDA recalls Z-0865-2024
  4. Registered EUDAMED 8406821BUG00225H6

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  • Withdrawn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
2354973 EUDAMED
H40402LS EUDAMED
8C-RS GUDID
Primary DI / UDI-DI
00840682106962
Basic UDI-DI
8406821BUG00225H6
Direct marketing DI
00840682106962
510(k) Number
FDA product code
IYN, IYO, ITX
EMDN code
Z110402010201 Curvilinear transcutaneous two–dimensional ultrasound probes (convex–array)
GMDN term
Extracorporeal ultrasound imaging transducer, hand-held
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
892.1550, 892.1560, 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
2354973
H40402LS
GUDID
8C-RS
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

Related devices

Category: Extracorporeal ultrasound imaging transducer, hand-held

Similar devices in this category

Other devices filed under CURVILINEAR TRANSCUTANEOUS TWO–DIMENSIONAL ULTRASOUND PROBES (CONVEX–ARRAY).

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)