ONEPASS NUCLEAR IMAGING SYSTEM, MODEL 70-500101


Device Classification Name

camera, scintillation (gamma)

510(k) Number K023373
Device Name ONEPASS NUCLEAR IMAGING SYSTEM, MODEL 70-500101
Original Applicant
GVI TECHNOLOGY PARTNERS
1470 enterprise pkwy.
twinsburg, 
OH 
44087

Original Contact kevin m nurrock
Regulation Number 892.1100
Classification Product Code
IYX  
Date Received 10/08/2002
Decision Date 01/03/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls