Identity
- Trade Name
- QVCAD System FDA UDI
- Generic Name
- Ultrasound imaging system application software FDA UDI
- Device Name
- Computer aided detection system of suspicious lesions in automated breast ultrasound images. FDA UDI
- Model / Reference
- 3.4.6 FDA UDI
- Description
- Computer aided detection system of suspicious lesions in automated breast ultrasound images. FDA UDI
Identifiers
- Primary DI / UDI-DI
- B630QVCS346 FDA UDI
- PMA Number
- P150043 FDA UDI
- FDA Product Code
- MYN FDA UDI
- GMDN Term
- Ultrasound imaging system application software FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.2070 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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
QVCAD System by Qview Medical, Inc. — 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
- Qview Medical, Inc.
Sources (1)
- FDA UDI dea0f343-9b4a-43a6-ad65-41170bfaf533 36 fields · synced Jun 8, 2026