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VitruvianScan (v1.0)
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
510(k) K241925Ref NA
Identity
- Trade Name
- VitruvianScan EUDAMED
- Device Name
- VitruvianScan EUDAMED
- Model / Reference
- NA EUDAMED
Identifiers
- Primary DI / UDI-DI
- +B554VSMD10/$+ 000N EUDAMED
- Basic UDI-DI
- ++B554VSMUK EUDAMED
- 510(k) Number
- K241925 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
- Market of Registration
- Netherlands 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
VitruvianScan (v1.0) by Perspectum, Ltd. — Class II — MDR, FDA_510K — listed in FDA 510(k), EUDAMED — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
MDR
United States Active
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K241925 | Class II | Active |
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Manufacturer
- Manufacturer
- Perspectum, Ltd.
Sources (2)
- FDA 510(k) K241925 24 fields · synced Jul 22, 2026
- EUDAMED 831a6f51-72ad-4686-bde1-a0b16d764325 61 fields · synced Jul 22, 2026