510(k) K901241

THORACIC/LUMBAR SPINE 8 RACETRACK COIL, 3080-64 by Medical Advances, Inc. — Product Code LNH

K901241 is an FDA 510(k) premarket notification submitted by Medical Advances, Inc. for the device "THORACIC/LUMBAR SPINE 8 RACETRACK COIL, 3080-64". The FDA issued a decision of Substantially Equivalent on Apr 25, 1990. The device falls under product code LNH (System, Nuclear Magnetic Resonance Imaging), a Class II device regulated under 21 CFR 892.1000. Medical Advances, Inc. has 56 other 510(k) clearances on record.

Clearance details

Decision
SESE (Substantially Equivalent)
Decision Date
Apr 25, 1990
Date Received
Mar 15, 1990
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
510(k)

Source: FDA 510(k) database entry for K901241. Report a data issue: hello@regdatalab.com.