PROGNOST ES, MODEL 0302 0000


Device Classification Name

system, x-ray, tomographic

510(k) Number K011290
Device Name PROGNOST ES, MODEL 0302 0000
Original Applicant
XMAR CORP.
2222 delaware dr.
cleveland heights, 
OH 
44106 -3115

Original Contact neil barrett
Regulation Number 892.1740
Classification Product Code
IZF  
Date Received 04/27/2001
Decision Date 05/30/2001
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

Type Traditional
Reviewed by Third Party No

Combination Product

No