510(k) K020164

E-SCAN XQ by Biosound Esaote, Inc. — Product Code LNH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 12, 2002
Date Received
January 17, 2002
Clearance Type
Special
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