510(k) K122026

PRISM ACQUIRE PRISM PROCESS PRISM VIEW by Prism Clinical Imaging, Inc. — Product Code LNH

K122026 is an FDA 510(k) premarket notification submitted by Prism Clinical Imaging, Inc. for the device "PRISM ACQUIRE PRISM PROCESS PRISM VIEW". The FDA issued a decision of Substantially Equivalent on September 21, 2012. The device falls under product code LNH (System, Nuclear Magnetic Resonance Imaging), a Class II device regulated under 21 CFR 892.1000. Prism Clinical Imaging, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 21, 2012
Date Received
July 11, 2012
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