PANATOME


Device Classification Name

unit, x-ray, extraoral with timer

510(k) Number K991518
Device Name PANATOME
Applicant
IMAGING SCIENCES INTL., INC.
1910 north penn rd.
hatfield, 
PA 
19440

Applicant Contact robert e hay
Correspondent
IMAGING SCIENCES INTL., INC.
1910 north penn rd.
hatfield, 
PA 
19440

Correspodent Contact robert e hay
Regulation Number 872.1800
Classification Product Code
EHD  
Date Received 04/30/1999
Decision Date 06/18/1999
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No