ACCUSOFT

System, Planning, Radiation Therapy Treatment

DIREX SYSTEMS CORP.

The following data is part of a premarket notification filed by Direx Systems Corp. with the FDA for Accusoft.

Pre-market Notification Details

• Device ID: K040474
• 510k Number: K040474
• Device Name: ACCUSOFT
• Classification: System, Planning, Radiation Therapy Treatment
• Applicant: DIREX SYSTEMS CORP. 11 MERCER RD. Natick, MA 01760
• Contact: Larisa Gerstein
• Correspondent: Larisa Gerstein; DIREX SYSTEMS CORP. 11 MERCER RD. Natick, MA 01760
• Product Code: MUJ
• CFR Regulation Number: 892.5050 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2004-02-24
• Decision Date: 2004-06-23
• Summary: summary