510(k) Premarket Notification

• Device Classification Name: accelerator, linear, medical
• 510(K) Number: K122616
• Model: VERSON 2.0
• Device Name: PANTHER OIS/R & V MODEL VERSION 2.0
• Applicant: PROWESS, INC.; 1844 clayton road; concord, CA 94520
• Contact: rachel scarano
• Regulation Number: 892.5050
• Classification Product Code: IYE
• Date Received: 09/05/2012
• Decision Date: 12/21/2012
• Decision: substantially equivalent (SE)
• Classification Advisory Committee: Radiology
• Review Advisory Committee: Radiology
• summary: summary
• Type: Traditional
• Reviewed by Third Party: No
• Expedited Review: No
• Combination Product: No