Device Classification Name |
Digitizer, Image, Radiological
|
510(k) Number |
K993599 |
Device Name |
DIAGNOSTIC PRO, MODEL 12772, VXR-16, MODEL 13020, VXR-16 DOSIMETRY PRO, MODEL 13019 |
Applicant |
VIDAR SYSTEMS CORP. |
460 SPRING PARK PL. |
HERNDON,
VA
20170
|
|
Applicant Contact |
MARY "PENNIE" DRINKARD |
Correspondent |
VIDAR SYSTEMS CORP. |
460 SPRING PARK PL. |
HERNDON,
VA
20170
|
|
Correspondent Contact |
MARY "PENNIE" DRINKARD |
Regulation Number | 892.2030
|
Classification Product Code |
|
Date Received | 10/25/1999 |
Decision Date | 01/18/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|