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510(k) K122026

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

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

Other clearances by Prism Clinical Imaging, Inc.

  • K082964 — PRISM ACQUIRE (VERSION 1.5), PRISM PROCESS (VERSION 1.5), PRISM VIEW (VERSION 2. (March 9, 2009)

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