The following data is part of a premarket notification filed by Vidar Systems Corp. with the FDA for Mammography Pro, Model 13017, Diagnostic Pro W/ Mammography Option, Model 13205.
| Device ID | K993598 |
| 510k Number | K993598 |
| Device Name: | MAMMOGRAPHY PRO, MODEL 13017, DIAGNOSTIC PRO W/ MAMMOGRAPHY OPTION, MODEL 13205 |
| 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 | 2000-01-20 |
| Summary: | summary |