MPOWER, MODEL 712 SERIES


Device Classification Name

system, tomography, computed, emission

510(k) Number K022001
Device Name MPOWER, MODEL 712 SERIES
Original Applicant
POSITRON CORP.
1304 langham creek dr., #300
houston, 
TX 
77084

Original Contact irene c albright
Regulation Number 892.1200
Classification Product Code
KPS  
Date Received 06/19/2002
Decision Date 07/12/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

statement

statement

Type Special
Reviewed by Third Party No

Combination Product

No