The following data is part of a premarket notification filed by Pie Medical Imaging B.v. with the FDA for Caas Qca 3d.
Device ID | K063344 |
510k Number | K063344 |
Device Name: | CAAS QCA 3D |
Classification | System, Image Processing, Radiological |
Applicant | PIE MEDICAL IMAGING B.V. BECANUSSTRAAT 13 D Maastricht, NL 6216 Bx |
Contact | Carla De Vries |
Correspondent | Carla De Vries PIE MEDICAL IMAGING B.V. BECANUSSTRAAT 13 D Maastricht, NL 6216 Bx |
Product Code | LLZ |
CFR Regulation Number | 892.2050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2006-11-06 |
Decision Date | 2006-11-28 |
Summary: | summary |