CAAS MR 4D Flow 1.1
CAAS MR 4D Flow 1.1 is a medical device (FDA Class II) made by Pie Medical Imaging B.V., cleared under FDA 510(k) K162376 on 8 Dec 2016 and listed in FDA GUDID since 18 Jan 2017 (UDI-DI 08056304453051), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number08056304453051 | Date18 Jan 2017 | StatusListed |
| United States | FDA 510(k)SESE | NumberK162376 | Date8 Dec 2016 | StatusActive |
Official records
- AccessGUDID record 08056304453051
- FDA 510(k) database K162376
Across registries
- FDA 510(k) K162376 decided 8 Dec 2016 Active
- FDA GUDID UDI-DI 08056304453051 listed 18 Jan 2017 Listed
Timeline
- Cleared FDA 510(k) K162376
- Listed FDA GUDID 08056304453051
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- CAAS MR 4D Flow
- Generic name
- Radiology DICOM image processing application software
- Model / reference
- 1.1
- Primary DI / UDI-DI
- 08056304453051
- 510(k) Number
- FDA product code
- LLZ, IZI
- GMDN term
- Radiology DICOM image processing application software
- Device class
- Class II
- Regulation number
- 892.2050, 892.1600
- GUDID distribution status
- In Commercial Distribution
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