MARK I THERMAL IMAGER


Device Classification Name

system, telethermographic (adjunctive use)

510(k) Number K023925
Device Name MARK I THERMAL IMAGER
Original Applicant
IX-DR, INC.
120 state
howell, 
MI 
48843

Original Contact william j o’neill
Regulation Number 884.2980
Classification Product Code
LHQ  
Date Received 11/25/2002
Decision Date 02/11/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Obstetrics/Gynecology

510k Review Panel

Radiology

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No