510(k) K884604

MT/S CARLSON SPINE COIL, PART # 100-50082500-01 by Diasonics, Inc. — Product Code LNH

K884604 is an FDA 510(k) premarket notification submitted by Diasonics, Inc. for the device "MT/S CARLSON SPINE COIL, PART # 100-50082500-01". The FDA issued a decision of Substantially Equivalent on November 30, 1988. The device falls under product code LNH (System, Nuclear Magnetic Resonance Imaging), a Class II device regulated under 21 CFR 892.1000. Diasonics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 30, 1988
Date Received
November 3, 1988
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