The following data is part of a premarket notification filed by Pie Medical Imaging B.v. with the FDA for Caas Mr 4d Flow.
Device ID | K162376 |
510k Number | K162376 |
Device Name: | CAAS MR 4D Flow |
Classification | System, Image Processing, Radiological |
Applicant | PIE MEDICAL IMAGING B.V. PHILIPSWEG 1 Maastricht, NL 6227 Aj |
Contact | Annemiek Bouts |
Correspondent | Annemiek Bouts PIE MEDICAL IMAGING B.V. PHILIPSWEG 1 Maastricht, NL 6227 Aj |
Product Code | LLZ |
CFR Regulation Number | 892.2050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2016-08-24 |
Decision Date | 2016-12-08 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
08056304453051 | K162376 | 000 |
08056304453433 | K162376 | 000 |