PRONEX

Accelerator, Linear, Medical

DIREX SYSTEMS CORP.

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

Pre-market Notification Details

• Device ID: K102765
• 510k Number: K102765
• Device Name: PRONEX
• Classification: Accelerator, Linear, Medical
• Applicant: DIREX SYSTEMS CORP. 437 TURNPIKE ST. Canton, MA 02021
• Contact: Larisa Gershtein
• Correspondent: Larisa Gershtein; DIREX SYSTEMS CORP. 437 TURNPIKE ST. Canton, MA 02021
• Product Code: IYE
• CFR Regulation Number: 892.5050 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2010-09-24
• Decision Date: 2010-12-07
• Summary: summary