The following data is part of a premarket notification filed by Vidar Systems Corp. with the FDA for Diagnostic Pro, Model 12772, Vxr-16, Model 13020, Vxr-16 Dosimetry Pro, Model 13019.
| Device ID | K993599 |
| 510k Number | K993599 |
| Device Name: | DIAGNOSTIC PRO, MODEL 12772, VXR-16, MODEL 13020, VXR-16 DOSIMETRY PRO, MODEL 13019 |
| Classification | Digitizer, Image, Radiological |
| Applicant | VIDAR SYSTEMS CORP. 460 SPRING PARK PL. Herndon, VA 20170 |
| Contact | Mary "pennie" Drinkard |
| Correspondent | Mary "pennie" Drinkard VIDAR SYSTEMS CORP. 460 SPRING PARK PL. 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 | 1999-10-25 |
| Decision Date | 2000-01-18 |
| Summary: | summary |