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LiverMultiScan
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref N/AModel v6.1Ref 3.5.0Model v3.5.0Ref LiverMultiScan v5510(k) K253413
Identity
- Trade Name
- LiverMultiScan EUDAMED
- Device Name
- LiverMultiScan EUDAMEDLiverMultiScan v5 EUDAMED
- Model / Reference
- v6.1 EUDAMEDN/A EUDAMEDv3.5.0 EUDAMED3.5.0 EUDAMEDLiverMultiScan v5 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05056849000010 EUDAMED*+B554LMS30B* EUDAMED+B554LMS50D EUDAMED
- Basic UDI-DI
- 5056849LMSGV EUDAMEDB-*+B554LMS30B* EUDAMED++B554LMSST EUDAMED
- 510(k) Number
- K253413 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 IIa EUDAMEDClass 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-1192 EUDAMED
- Market of Registration
- Netherlands EUDAMEDPortugal 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
EUDAMEDEUDAMED
Incorporates Medicinal Product
No
EUDAMED
LiverMultiScan by Perspectum, Ltd. — Class IIa — FDA_510K, MDR, MDD — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
United States Active
FDA_510K
European Union Active
CE/MDR
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K202170 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K253413 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 5056849LMSGV | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | 5056849LMSGV | Class IIa | Active |
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Manufacturer
- Manufacturer
- Perspectum Ltd
- EUDAMED SRN
- GB-MF-000016685
- Authorised Representative
- Perspectum Unipessoal Lda PT-AR-000009160
Sources (4)
- EUDAMED 1916a8a4-3d8a-4fcb-a036-759daf913e09 61 fields · synced Jul 17, 2026
- EUDAMED 4e6f1f65-23e4-45d1-b87e-747f7c82258e 61 fields · synced May 17, 2026
- EUDAMED 97c4596c-7938-40a4-899f-f96d9ed6db69 61 fields · synced May 18, 2026
- FDA 510(k) K253413 24 fields · synced May 18, 2026