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Hepatogram plus

by Resoundant

Ref RESMPLSAModel Hepatogram plus v3

Hepatogram plus (RESMPLSA) is a device classified as Class IIa in the EU and Class II in the US made by Resoundant, registered in EUDAMED on 15 Jul 2024 (Basic UDI-DI B-00850011790199), cleared under FDA 510(k) K183193 on 1 Aug 2019 and listed in FDA GUDID since 13 Apr 2022 (UDI-DI 00850011790199), active as of 22 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDD 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) K183193

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/MDD EUDAMED NumberB-00850011790199 Basic UDI-DI 00850011790199UDI-DIDate15 Jul 2024RegisteredStatusActive
United StatesGUDID listing GUDID Number00850011790199 UDI-DI Date13 Apr 2022ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK183193 Date1 Aug 2019DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-00850011790199 registered 15 Jul 2024 Active
  • FDA 510(k) K183193 decided 1 Aug 2019 Active
  • FDA GUDID UDI-DI 00850011790199 listed 13 Apr 2022 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K183193
  2. Listed FDA GUDID 00850011790199
  3. Registered EUDAMED B-00850011790199

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Generic name
MRI system application software
Model / Ref / Catalog
Hepatogram plus v3 EUDAMED
RESMPLSA EUDAMED
3.0DKR GUDID
MREPLUSV3 GUDID
Primary DI / UDI-DI
00850011790199
Basic UDI-DI
B-00850011790199
510(k) Number
FDA product code
LLZ
EMDN code
Z11059082 Various magnetic resonance imaging instruments - software accessories
GMDN term
MRI system application software
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
892.2050
System or procedure pack
System which is a device in itself
EU registration type
Legacy device (under a directive)
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
Hepatogram plus v3
RESMPLSA
GUDID
3.0DKR
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-000037180
Authorised representative
VISAMED GmbH DE-AR-000006285

Similar devices in this category

Other devices filed under VARIOUS MAGNETIC RESONANCE IMAGING (MRI) INSTRUMENTS.

Other devices from Resoundant

See all devices from Resoundant →

Properties

  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (20, all answered No)