The following data is part of a premarket notification filed by Synca Marketing, Inc. with the FDA for Cadi, Version 4.
| Device ID | K062237 |
| 510k Number | K062237 |
| Device Name: | CADI, VERSION 4 |
| Classification | System, Image Processing, Radiological |
| Applicant | SYNCA MARKETING, INC. 337 MARION STREET Le Gardeur, Quebec, CA J5z 4w8 |
| Contact | Stephane Arsenault |
| Correspondent | Stephane Arsenault SYNCA MARKETING, INC. 337 MARION STREET Le Gardeur, Quebec, CA J5z 4w8 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-08-02 |
| Decision Date | 2006-11-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00667147001545 | K062237 | 000 |
| 00066714700155 | K062237 | 000 |