The following data is part of a premarket notification filed by Imaging Dynamics Company Limited with the FDA for Xplorer 1600.
| Device ID | K042041 |
| 510k Number | K042041 |
| Device Name: | XPLORER 1600 |
| Classification | Solid State X-ray Imager (flat Panel/digital Imager) |
| Applicant | IMAGING DYNAMICS COMPANY LIMITED 151,2340 PEGASUS WAY NE Calgary, CA T3g3x5 |
| Contact | Robin Winsor |
| Correspondent | Robin Winsor IMAGING DYNAMICS COMPANY LIMITED 151,2340 PEGASUS WAY NE Calgary, CA T3g3x5 |
| Product Code | MQB |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-07-29 |
| Decision Date | 2004-09-17 |