← Back to catalogue

Hepatica

EUDAMEDFDA 510(k)

Class IIb (EU MDR)

Ref v1Model Hepatica v1510(k) K203280

by Perspectum Ltd

Identity

Trade Name
Hepatica EUDAMED
Device Name
Hepatica EUDAMED
Model / Reference
Hepatica v1 EUDAMED
v1 EUDAMED

Identifiers

Primary DI / UDI-DI
+B554HEPATICA10U EUDAMED
Basic UDI-DI
++B554HepaticaH2 EUDAMED
510(k) Number
K203280 FDA 510(k)
FDA Product Code
LNH FDA 510(k)
EMDN Code
Z11059082 VARIOUS MAGNETIC RESONANCE IMAGING INSTRUMENTS - SOFTWARE ACCESSORIES EUDAMED

Classification

Device Class
Class IIb EUDAMED
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 892.1000 FDA 510(k)
Regulation Number
892.1000 FDA 510(k)
Special Device Type
Software EUDAMED
Market of Registration
Portugal EUDAMED
Advisory Committee
Radiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

Clinical & Handling

Sterile

No

EUDAMED

Implantable

No

EUDAMED

Reusable

No

EUDAMED

Contains Latex

No

EUDAMED

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

Yes

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Hepatica by Perspectum, Ltd. — Class IIb — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

United States Active

FDA_510K

European Union Active

CE/MDR

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Perspectum Ltd
EUDAMED SRN
GB-MF-000016685
Authorised Representative
Perspectum Unipessoal Lda PT-AR-000009160

Sources (3)

  • EUDAMED f5e887b9-4294-4c6a-91b2-e30c3dec4773 61 fields · synced Jul 23, 2026
  • FDA 510(k) K203280 24 fields · synced May 18, 2026
  • EUDAMED 97c76456-4ee4-4d1b-bc8b-3ef1e36ec9aa 61 fields · synced Jul 23, 2026