ACHIEVA R4 1.5T AND ACHIEVA R4 3.0T


Device Classification Name

system, nuclear magnetic resonance imaging

510(k) Number K110151
Device Name ACHIEVA R4 1.5T AND ACHIEVA R4 3.0T
Applicant
PHILIPS HEALTHCARE
22100 bothell everett highway
bothell, 
WA 
98021

Applicant Contact lynn harmer
Correspondent
PHILIPS HEALTHCARE
22100 bothell everett highway
bothell, 
WA 
98021

Correspodent Contact lynn harmer
Regulation Number 892.1000
Classification Product Code
LNH  
Date Received 01/18/2011
Decision Date 03/22/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

Yes

Recalls CDRH Recalls