CAAS MR 4D Flow
510(k) K162376
CAAS MR 4D Flow is a medical device (FDA Class II; FDA product code LLZ, System, Image Processing, Radiological) made by Pie Medical Imaging BV, cleared under FDA 510(k) K162376 on 8 Dec 2016, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK162376 | Date8 Dec 2016 | StatusActive |
Official records
- FDA 510(k) database K162376
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- LLZ
- Device class
- Class II
- Regulation
- 21 CFR Part 892.2050
- Advisory committee
- Radiology
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K162376
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| CAAS MR 4D Flow 1.1 | 1.1 | 08056304453051 | — | On the market |
| CAAS MR 4D Flow 2.0 | 2.0 | 08056304453433 | — | On the market |
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