The following data is part of a premarket notification filed by Vidar Systems Corp. with the FDA for Vidar Dental Film Digitizer.
| Device ID | K093809 |
| 510k Number | K093809 |
| Device Name: | VIDAR DENTAL FILM DIGITIZER |
| Classification | Digitizer, Image, Radiological |
| Applicant | VIDAR SYSTEMS CORP. 365 HERNDON PARKWAY Herndon, VA 20170 |
| Contact | Carrie L Brancart |
| Correspondent | John Howlett BSI HEALTHCARE KITEMARK COURT, DAVY AVENUE KNOWLHILL Milton Keynes, GB Mk5 8pp |
| Product Code | LMA |
| CFR Regulation Number | 892.2030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2009-12-09 |
| Decision Date | 2010-01-07 |
| Summary: | summary |