Identity
- Trade Name
- VitruvianScan FDA UDI
- Generic Name
- Radiology DICOM image processing application software FDA UDI
- Device Name
- VitruvianScan is a standalone, post processing software as a medical device (SaMD). VitruvianScan enables the generation, display and review of magnetic resonance (MR) medical image data from a single timepoint (one patient visit). FDA UDI
- Model / Reference
- 1.0 FDA UDI
- Description
- VitruvianScan is a standalone, post processing software as a medical device (SaMD). VitruvianScan enables the generation, display and review of magnetic resonance (MR) medical image data from a single timepoint (one patient visit). FDA UDI
Identifiers
- Primary DI / UDI-DI
- B554VSMD1000 FDA UDI
- FDA Product Code
- LNH FDA UDI
- GMDN Term
- Radiology DICOM image processing application software FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1000 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Radiology DICOM image processing application software
VitruvianScan by Perspectum — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Perspectum
Sources (1)
- FDA UDI 1eb3eb71-b9ef-4f64-ab2a-1938a882cfe6 33 fields · synced May 30, 2026