SEQUENCER

Accelerator, Linear, Medical

IMPAC MEDICAL SYSTEMS, INC.

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

Pre-market Notification Details

• Device ID: K981313
• 510k Number: K981313
• Device Name: SEQUENCER
• Classification: Accelerator, Linear, Medical
• Applicant: IMPAC MEDICAL SYSTEMS, INC. 215 CASTRO ST. Mountain View, CA 94041 -1203
• Contact: James Hoey
• Correspondent: James Hoey; IMPAC MEDICAL SYSTEMS, INC. 215 CASTRO ST. Mountain View, CA 94041 -1203
• Product Code: IYE
• CFR Regulation Number: 892.5050 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1998-04-10
• Decision Date: 1998-07-09
• Summary: summary