INTERA FAMILY


Device Classification Name

system, nuclear magnetic resonance imaging

510(k) Number K030520
Device Name INTERA FAMILY
Applicant
PHILIPS MEDICAL SYSTEMS NORTH AMERICA CO.
22100 bothell everett hwy.
p.o. box 3003
bothell, 
WA 
98041 -3003

Applicant Contact lynn harmer
Regulation Number 892.1000
Classification Product Code
LNH  
Date Received 02/19/2003
Decision Date 03/06/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party Yes

Combination Product

No