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Shape Coil Q7000198

by Quality Electrodynamics LLC

Part of a family of 49 devices: see the family page

Ref Q7000198

Shape Coil Q7000198 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 29 Nov 2023 (Basic UDI-DI 081484802RFCOILBV), cleared under FDA 510(k) K200477 on 8 Apr 2020 and listed in FDA GUDID since 20 Aug 2021 (UDI-DI 00814848020546), 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) K200477

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 Number081484802RFCOILBV Basic UDI-DI 00814848020546UDI-DIDate29 Nov 2023RegisteredStatusActive
United StatesGUDID listing GUDID Number00814848020546 UDI-DI Date20 Aug 2021ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK200477 Date8 Apr 2020DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 081484802RFCOILBV registered 29 Nov 2023 Active
  • FDA 510(k) K200477 decided 8 Apr 2020 Active
  • FDA GUDID UDI-DI 00814848020546 listed 20 Aug 2021 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K200477
  2. Listed FDA GUDID 00814848020546
  3. Registered EUDAMED 081484802RFCOILBV

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  • Withdrawn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
Shape Coil
Generic name
MRI system coil, radio-frequency
Device name
MRI RF Coils
Model / reference
Q7000198
Primary DI / UDI-DI
00814848020546
Basic UDI-DI
081484802RFCOILBV
Direct marketing DI
00814848020546
510(k) Number
FDA product code
MOS
EMDN code
Z1105018001 Magnetic resonance (MR) radiofrequency surface coils
GMDN term
MRI system coil, radio-frequency
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
892.1000
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: MRI system coil, radio-frequency

Similar devices in this category

Other devices filed under MAGNETIC RESONANCE (MR) RADIOFREQUENCY SURFACE COILS.

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)