EFILM WORKSTATION

System, Image Processing, Radiological

EFILM MEDICAL, INC.

The following data is part of a premarket notification filed by Efilm Medical, Inc. with the FDA for Efilm Workstation.

Pre-market Notification Details

• Device ID: K012211
• 510k Number: K012211
• Device Name: EFILM WORKSTATION
• Classification: System, Image Processing, Radiological
• Applicant: EFILM MEDICAL, INC. 500 UNIVERSITY AVE., SUITE 300 Toronto, Ontario, CA M5g 1v7
• Contact: Kathy Chin
• Correspondent: N.e. Devine; ENTELA, INC. 3033 MADISON AVENUE, SE Grand Rapids, MI 49548
• Product Code: LLZ
• CFR Regulation Number: 892.2050 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: Yes
• Combination Product: No
• Date Received: 2001-07-16
• Decision Date: 2001-07-31
• Summary: summary