INTRAORAL IMAGING SYSTEM, MODEL SUNI-RAY


Device Classification Name

system,x-ray,extraoral source,digital

510(k) Number K021718
Device Name INTRAORAL IMAGING SYSTEM, MODEL SUNI-RAY
Original Applicant
SUNI IMAGING MICROSYSTEMS, INC.
6840 via del oro, suite 10
san jose, 
CA 
95119

Original Contact f. al bettencourt
Regulation Number 872.1800
Classification Product Code
MUH  
Date Received 05/23/2002
Decision Date 08/15/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Radiology

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No