PS 3000 DIGATAL PHOTOSPOT SYSTEM


Device Classification Name

interventional fluoroscopic x-ray system

510(k) Number K030061
Device Name PS 3000 DIGATAL PHOTOSPOT SYSTEM
Original Applicant
PRECISE OPTICS
1151 hope st.
stamford, 
CT 
06907

Original Contact richard keen
Regulation Number 892.1650
Classification Product Code
OWB  
Subsequent Product Code
JAA  
Date Received 01/07/2003
Decision Date 04/07/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No