The following data is part of a premarket notification filed by Vidar Systems Corp. with the FDA for Teleradpro Edge; Teleradpro Edge Hd-ccd.
| Device ID | K130636 |
| 510k Number | K130636 |
| Device Name: | TELERADPRO EDGE; TELERADPRO EDGE HD-CCD |
| Classification | Digitizer, Image, Radiological |
| Applicant | VIDAR SYSTEMS CORP. 365 Herndon Pkwy Herndon, VA 20170 |
| Contact | Carrie L Brancart |
| Correspondent | Carrie L Brancart VIDAR SYSTEMS CORP. 365 Herndon Pkwy Herndon, VA 20170 |
| Product Code | LMA |
| CFR Regulation Number | 892.2030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-03-11 |
| Decision Date | 2013-06-07 |
| Summary: | summary |