The following data is part of a premarket notification filed by Imaging Dynamics Company Ltd. with the FDA for Xplorer 1600 Plus.
| Device ID | K062586 |
| 510k Number | K062586 |
| Device Name: | XPLORER 1600 PLUS |
| Classification | Solid State X-ray Imager (flat Panel/digital Imager) |
| Applicant | IMAGING DYNAMICS COMPANY LTD. 151,2340 PEGASUS WAY, NE Calgary, Alberta, CA T2e 8m5 |
| Contact | Shirantha Samarappuli |
| Correspondent | Shirantha Samarappuli IMAGING DYNAMICS COMPANY LTD. 151,2340 PEGASUS WAY, NE Calgary, Alberta, CA T2e 8m5 |
| Product Code | MQB |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-09-01 |
| Decision Date | 2006-09-29 |