PVMED DDR 2520 DIGITAL IMAGING SYSTEM


Device Classification Name

system, imaging, x-ray, electrostatic

510(k) Number K072766
Device Name PVMED DDR 2520 DIGITAL IMAGING SYSTEM
Applicant
PORTAVISION MEDICAL
1705 s. capital of texas hwy.
suite 500
austin, 
TX 
78746

Applicant Contact ian gorden
Regulation Number 892.1630
Classification Product Code
IXK  
Date Received 09/28/2007
Decision Date 12/11/2007
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party Yes

Combination Product

No