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Mrcp+

by Perspectum Ltd

Ref 1.01Model v1.01510(k) K183133

Mrcp+ (1.01) is a device classified as Class I in the EU and Class II in the US made by Perspectum, Ltd., registered in EUDAMED on 14 Sep 2022 (Basic UDI-DI B-+B554MRCP10) and cleared under FDA 510(k) K183133 on 9 Jan 2019, active as of 24 Oct 2026.

Active European Union and United States

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 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K183133↗

FDA record

Trust

Unverified

Source EUDAMED, FDA 510(k), synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-+B554MRCP10 Basic UDI-DI +B554MRCP10UDI-DIDate14 Sep 2022RegisteredStatusActive
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK183133 Date9 Jan 2019ClearedStatusActive

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-+B554MRCP10 registered 14 Sep 2022 Active
  • FDA 510(k) K183133 decided 9 Jan 2019 Active

Timeline

2 dated events

  1. Cleared FDA 510(k) K183133
  2. Registered EUDAMED B-+B554MRCP10

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · 510(k)

Model / reference
v1.01, 1.01
Primary DI / UDI-DI
+B554MRCP10
Basic UDI-DI
B-+B554MRCP10
510(k) Number
FDA product code
LLZ
EMDN code
Z11059082 Various magnetic resonance imaging instruments - software accessories
Device class
Class I EUDAMED
Class II 510(k)
Regulation
21 CFR Part 892.2050
EU registration type
Legacy device (under a directive)
EU market of registration
Portugal
Advisory committee
Radiology
FDA decision
SESE Substantially Equivalent

Truth per registry

2 sources · 1 field differs

FieldEUDAMED510(k)
Device classEUDAMED
Class I
510(k)
Class II

Device class is stated on each registry's own scale: Class I in the EU (EUDAMED), Class II in the US (FDA 510(k)). EU and US classes are different schemes, so this is not a disagreement.

Related clearances

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Cited by

Source: 510k-lineage (choiben314), CC BY 4.0

Manufacturer details

EUDAMED SRN
GB-MF-000016685
Authorised representative
Perspectum Unipessoal Lda PT-AR-000009160

Similar devices in this category

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

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Properties

Other properties (12, all answered No)