510(k) K093738

MRI PATIENT POSITIONING DEVICES by Medtec, Inc. — Product Code LNH

K093738 is an FDA 510(k) premarket notification submitted by Medtec, Inc. for the device "MRI PATIENT POSITIONING DEVICES". The FDA issued a decision of Substantially Equivalent on May 14, 2010. The device falls under product code LNH (System, Nuclear Magnetic Resonance Imaging), a Class II device regulated under 21 CFR 892.1000. Medtec, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 14, 2010
Date Received
December 4, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

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