510(k) Premarket Notification

• Device Classification Name: system, nuclear magnetic resonance imaging
• 510(K) Number: K122026
• Model: VERISON 4.0
• Device Name: PRISM ACQUIRE PRISM PROCESS PRISM VIEW
• Applicant: PRISM CLINICAL IMAGING, INC.; 890 elm grove rd., suite 215; elm grove, WI 53122
• Contact: james l reuss
• Regulation Number: 892.1000
• Classification Product Code: LNH
• Subsequent Product Code: LLZ
• Date Received: 07/11/2012
• Decision Date: 09/21/2012
• Decision: substantially equivalent (SE)
• Classification Advisory Committee: Radiology
• Review Advisory Committee: Radiology
• summary: summary
• Type: Special
• Reviewed by Third Party: No
• Expedited Review: No
• Combination Product: No