The following data is part of a premarket notification filed by Imaging Dynamics Company Ltd. with the FDA for X3c 1600 Digital Radiographic System.
| Device ID | K071403 |
| 510k Number | K071403 |
| Device Name: | X3C 1600 DIGITAL RADIOGRAPHIC SYSTEM |
| Classification | System, X-ray, Stationary |
| Applicant | IMAGING DYNAMICS COMPANY LTD. 2340 PEGASUS WAY, NE SUITE 151 Calgary, CA T2e 8m5 |
| Contact | Shiranthan Samarappuli |
| Correspondent | Shiranthan Samarappuli IMAGING DYNAMICS COMPANY LTD. 2340 PEGASUS WAY, NE SUITE 151 Calgary, CA T2e 8m5 |
| Product Code | KPR |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-05-21 |
| Decision Date | 2007-06-11 |
| Summary: | summary |