PRIMUS

Accelerator, Linear, Medical

SIEMENS MEDICAL SOLUTIONS USA, INC.

The following data is part of a premarket notification filed by Siemens Medical Solutions Usa, Inc. with the FDA for Primus.

Pre-market Notification Details

• Device ID: K993425
• 510k Number: K993425
• Device Name: PRIMUS
• Classification: Accelerator, Linear, Medical
• Applicant: SIEMENS MEDICAL SOLUTIONS USA, INC. 4040 NELSON AVE. Concord, CA 94520
• Contact: Kathryn B Dodd
• Correspondent: Kathryn B Dodd; SIEMENS MEDICAL SOLUTIONS USA, INC. 4040 NELSON AVE. Concord, CA 94520
• Product Code: IYE
• CFR Regulation Number: 892.5050 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1999-10-12
• Decision Date: 1999-11-26
• Summary: summary