The following data is part of a premarket notification filed by Vidar Systems Corp. with the FDA for Expresssuite.
| Device ID | K011049 |
| 510k Number | K011049 |
| Device Name: | EXPRESSSUITE |
| Classification | Digitizer, Image, Radiological |
| Applicant | VIDAR SYSTEMS CORP. 460 SPRING PARK PL. Herndon, VA 20170 |
| Contact | Mary Harp |
| Correspondent | Mary Harp 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 | 2001-04-06 |
| Decision Date | 2001-10-01 |