The following data is part of a premarket notification filed by Vidar Systems Corp. with the FDA for Medscan 12.
| Device ID | K933632 |
| 510k Number | K933632 |
| Device Name: | MEDSCAN 12 |
| Classification | Digitizer, Image, Radiological |
| Applicant | VIDAR SYSTEMS CORP. TRUVEL DIVISION 520 D HERNDON PARKWAY Herndon, VA 22070 |
| Contact | Charles R Coleman |
| Correspondent | Charles R Coleman VIDAR SYSTEMS CORP. TRUVEL DIVISION 520 D HERNDON PARKWAY Herndon, VA 22070 |
| Product Code | LMA |
| CFR Regulation Number | 892.2030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-07-27 |
| Decision Date | 1993-12-13 |