The following data is part of a premarket notification filed by Vidar Systems Corp. with the FDA for Vidar Vision 3000 And 4000 X-ray Systems.
Device ID | K071193 |
510k Number | K071193 |
Device Name: | VIDAR VISION 3000 AND 4000 X-RAY SYSTEMS |
Classification | Solid State X-ray Imager (flat Panel/digital Imager) |
Applicant | VIDAR SYSTEMS CORP. PO BOX 7007 Deerfield, IL 60015 |
Contact | Daniel Kamm |
Correspondent | Daniel Kamm VIDAR SYSTEMS CORP. PO BOX 7007 Deerfield, IL 60015 |
Product Code | MQB |
CFR Regulation Number | 892.1680 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2007-04-30 |
Decision Date | 2007-05-30 |
Summary: | summary |