The following data is part of a premarket notification filed by Vidar Systems Corp. with the FDA for Teleradpro.
Device ID | K102476 |
510k Number | K102476 |
Device Name: | TELERADPRO |
Classification | Digitizer, Image, Radiological |
Applicant | VIDAR SYSTEMS CORP. 365 HERNDON PARKWAY Herndon, VA 20170 |
Contact | Carrie L Brancart |
Correspondent | Carrie L Brancart VIDAR SYSTEMS CORP. 365 HERNDON PARKWAY Herndon, VA 20170 |
Product Code | LMA |
CFR Regulation Number | 892.2030 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2010-08-30 |
Decision Date | 2010-10-07 |
Summary: | summary |