I-BEAM

Accelerator, Linear, Medical

COMPUTERIZED MEDICAL SYSTEMS, INC.

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

Pre-market Notification Details

• Device ID: K032100
• 510k Number: K032100
• Device Name: I-BEAM
• Classification: Accelerator, Linear, Medical
• Applicant: COMPUTERIZED MEDICAL SYSTEMS, INC. 1145 CORPORATE LAKE DR. St. Louis, MO 63132 -1716
• Contact: Kathryn Stinson
• Correspondent: Kathryn Stinson; COMPUTERIZED MEDICAL SYSTEMS, INC. 1145 CORPORATE LAKE DR. St. Louis, MO 63132 -1716
• Product Code: IYE
• CFR Regulation Number: 892.5050 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2003-07-08
• Decision Date: 2003-10-02
• Summary: summary