QPLAQUE MR


Device Classification Name

system, nuclear magnetic resonance imaging

510(k) Number K073156
Device Name QPLAQUE MR
Applicant
MEDIS MEDICAL IMAGING SYSTEMS, B.V.
9 schuttersveld
p.o. box 384
leiden, 

NL

2316 xg

Applicant Contact j.i. hollander
Correspondent
MEDIS MEDICAL IMAGING SYSTEMS, B.V.
9 schuttersveld
p.o. box 384
leiden, 

NL

2316 xg

Correspodent Contact j.i. hollander
Regulation Number 892.1000
Classification Product Code
LNH  
Date Received 11/08/2007
Decision Date 03/04/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No