The following data is part of a premarket notification filed by Vidar Systems Corp. with the FDA for Vidar Vxr Ls Laser Film Digitizer.
Device ID | K974315 |
510k Number | K974315 |
Device Name: | VIDAR VXR LS LASER FILM DIGITIZER |
Classification | Digitizer, Image, Radiological |
Applicant | VIDAR SYSTEMS CORP. 460 SPRING PARK PL. Herndon, VA 20170 |
Contact | Billy Stamper |
Correspondent | Billy Stamper 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 | 1997-11-17 |
Decision Date | 1998-04-17 |
Summary: | summary |