510(k) K043147

ACHIEVA FAMILY by Philips Medical Systems North America Co. — Product Code LNH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 15, 2005
Date Received
November 15, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Nuclear Magnetic Resonance Imaging
Device Class
Class II
Regulation Number
892.1000
Review Panel
RA
Submission Type