Skip to content

SureWave Elastography Q7000225

by Quality Electrodynamics LLC

Ref Q7000225

SureWave Elastography Q7000225 is a device classified as Class IIa in the EU and Class II in the US made by Quality Electrodynamics LLC, registered in EUDAMED on 9 Dec 2025 (Basic UDI-DI 081484802MREH6), cleared under FDA 510(k) K242006 on 12 Feb 2025 and listed in FDA GUDID since 12 Apr 2025 (UDI-DI 00814848020775), active as of 25 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 25 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K242006

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number081484802MREH6 Basic UDI-DI 00814848020775UDI-DIDate9 Dec 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number00814848020775 UDI-DI Date12 Apr 2025ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK242006 Date12 Feb 2025DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 081484802MREH6 registered 9 Dec 2025 Active
  • FDA 510(k) K242006 decided 12 Feb 2025 Active
  • FDA GUDID UDI-DI 00814848020775 listed 12 Apr 2025 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K242006
  2. Listed FDA GUDID 00814848020775
  3. Registered EUDAMED 081484802MREH6

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  • Withdrawn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

Trade name
SureWave Elastography
Generic name
Magnetic resonance elastography acoustic driver
Device name
MR Elastography
Model / reference
Q7000225
Primary DI / UDI-DI
00814848020775
Basic UDI-DI
081484802MREH6
Direct marketing DI
00814848020775
510(k) Number
FDA product code
LNH
EMDN code
Z1105018099 Magnetic resonance (MR) systems - hardware accessories - other
GMDN term
Magnetic resonance elastography acoustic driver
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
892.1000
System or procedure pack
System which is a device in itself
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
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.

Related devices

Category: Magnetic resonance elastography acoustic driver

Similar devices in this category

Other devices filed under MAGNETIC RESONANCE (MR) SYSTEMS - HARDWARE ACCESSORIES - OTHER.

Other devices from Quality Electrodynamics LLC

See all devices from Quality Electrodynamics LLC →

Properties

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