The following data is part of a premarket notification filed by Dog Microsystems, Inc. with the FDA for Cadens (tm) Colon.
| Device ID | K111758 |
| 510k Number | K111758 |
| Device Name: | CADENS (TM) COLON |
| Classification | System, Image Processing, Radiological |
| Applicant | DOG MICROSYSTEMS, INC. 116 PRINCIPALE SUITE 200 Granby, Quebec, CA J2g 2v2 |
| Contact | Florent Chandelier |
| Correspondent | Florent Chandelier DOG MICROSYSTEMS, INC. 116 PRINCIPALE SUITE 200 Granby, Quebec, CA J2g 2v2 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-06-22 |
| Decision Date | 2012-02-14 |
| Summary: | summary |