The following data is part of a premarket notification filed by Vidar Systems Corp. with the FDA for Vidar Vision 2000.
| Device ID | K070563 |
| 510k Number | K070563 |
| Device Name: | VIDAR VISION 2000 |
| Classification | Solid State X-ray Imager (flat Panel/digital Imager) |
| Applicant | VIDAR SYSTEMS CORP. 75 ORCHARD SPRING ESTS. Waterbury, VT 05676 |
| Contact | James M Taylor |
| Correspondent | John Howlett BSI HEALTHCARE KITEMARK COURT, DAVY AVENUE KNOWLHILL Milton Keynes, GB Mk5 8pp |
| Product Code | MQB |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2007-02-27 |
| Decision Date | 2007-03-16 |