FOCUS

System, Planning, Radiation Therapy Treatment

COMPUTERIZED MEDICAL SYSTEMS, INC.

The following data is part of a premarket notification filed by Computerized Medical Systems, Inc. with the FDA for Focus.

Pre-market Notification Details

• Device ID: K002147
• 510k Number: K002147
• Device Name: FOCUS
• Classification: System, Planning, Radiation Therapy Treatment
• Applicant: COMPUTERIZED MEDICAL SYSTEMS, INC. 1145 CORPORATE LAKE DR. SUITE 100 St. Louis, MO 63132 -1716
• Contact: Michael A Parsons
• Correspondent: Michael A Parsons; COMPUTERIZED MEDICAL SYSTEMS, INC. 1145 CORPORATE LAKE DR. SUITE 100 St. Louis, MO 63132 -1716
• Product Code: MUJ
• CFR Regulation Number: 892.5050 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2000-07-17
• Decision Date: 2000-10-13