Identity
- Trade Name
- VolparaDensity FDA UDI
- Generic Name
- Radiology DICOM image processing application software FDA UDI
- Device Name
- VolparaDensity 3.2 (Volpara Imaging Software 1.5.2) FDA UDI
- Model / Reference
- 3.2 FDA UDI
- Description
- VolparaDensity 3.2 (Volpara Imaging Software 1.5.2) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 09421904268029 FDA UDI
- 510(k) Number
- K153427 FDA UDI
- FDA Product Code
- LLZ FDA UDI
- GMDN Term
- Radiology DICOM image processing application software FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.2050 FDA UDI
- Commercial Distribution
- Not 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
No
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
VolparaDensity by Volpara Health Technologies Limited — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
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
- Volpara Health Technologies Limited
Sources (1)
- FDA UDI 4b8e38a8-3013-4db1-8daa-3129ea79d7ab 35 fields · synced Jun 8, 2026