EZ-SCOPE AN, EZ-SCOPE LIGHT


Device Classification Name

camera, scintillation (gamma)

510(k) Number K022342
Device Name EZ-SCOPE AN, EZ-SCOPE LIGHT
Original Applicant
ANZAI MEDICAL CO, LTD.
2305 gold mine rd.
brookeville, 
MD 
20833 -2233

Original Contact t. whit athey
Regulation Number 892.1100
Classification Product Code
IYX  
Date Received 07/18/2002
Decision Date 10/09/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No