PROWESS

System, Planning, Radiation Therapy Treatment

PROWESS, INC.

The following data is part of a premarket notification filed by Prowess, Inc. with the FDA for Prowess.

Pre-market Notification Details

• Device ID: K032456
• 510k Number: K032456
• Device Name: PROWESS
• Classification: System, Planning, Radiation Therapy Treatment
• Applicant: PROWESS, INC. 1370 RIDGEWOOD DR., #20 Chico, CA 95973 -7803
• Contact: W. James Bishop
• Correspondent: W. James Bishop; PROWESS, INC. 1370 RIDGEWOOD DR., #20 Chico, CA 95973 -7803
• Product Code: MUJ
• CFR Regulation Number: 892.5050 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2003-08-11
• Decision Date: 2003-10-16
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00868603000236	K032456	000
00859032007002	K032456	000
00859032007064	K032456	000