EXPLORER GRADIENT


the company

Device Classification Name

system, nuclear magnetic resonance imaging

510(k) Number K001987
Device Name EXPLORER GRADIENT
Original Applicant
PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC.
710 bridgeport ave.
p.o. box 860
shelton, 
CT 
06484 -0197

Original Contact peter altman
Regulation Number 892.1000
Classification Product Code
LNH  
Date Received 06/29/2000
Decision Date 09/06/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

Type Traditional
Reviewed by Third Party No

Combination Product

No