QVCAD System 3.4.6
QVCAD System 3.4.6, an ultrasound imaging system application software (FDA Class II; FDA product code MYN, Analyzer, Medical Image) made by Qview Medical, Inc., was approved under FDA PMA P150043 on 9 Nov 2016 and listed in FDA GUDID on 26 Jun 2024 (UDI-DI B630QVCS346); the registry lists it as not in commercial distribution (GUDID) as of 23 Oct 2026.
Active
PMA
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | NumberB630QVCS346 | Date26 Jun 2024 | StatusListed |
| United States | FDA PMAAPRL | NumberP150043 | Date9 Nov 2016 | StatusActive |
Official records
- FDA PMA database P150043
Across registries
- FDA PMA P150043 decided 9 Nov 2016 Active
- FDA GUDID UDI-DI B630QVCS346 listed 26 Jun 2024 Listed
Timeline
- Approved FDA PMA P150043
- Listed FDA GUDID B630QVCS346
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA PMA Active
Specification
- Trade name
- QVCAD System
- Generic name
- Ultrasound imaging system application software
- Model / reference
- 3.4.6
- Primary DI / UDI-DI
- B630QVCS346
- PMA number
- FDA product code
- MYN
- GMDN term
- Ultrasound imaging system application software
- Device class
- Class II
- Regulation number
- 892.2070
- GUDID distribution status
- Not in Commercial Distribution
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