OPTIVIEW

System, Image Processing, Radiological

OPTIMED TECHNOLOGIES, INC.

The following data is part of a premarket notification filed by Optimed Technologies, Inc. with the FDA for Optiview.

Pre-market Notification Details

• Device ID: K972520
• 510k Number: K972520
• Device Name: OPTIVIEW
• Classification: System, Image Processing, Radiological
• Applicant: OPTIMED TECHNOLOGIES, INC. 293 EISENHOWER PKWY. Livingston, NJ 07039
• Contact: Moshe Zchut
• Correspondent: Moshe Zchut; OPTIMED TECHNOLOGIES, INC. 293 EISENHOWER PKWY. Livingston, NJ 07039
• Product Code: LLZ
• CFR Regulation Number: 892.2050 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1997-07-07
• Decision Date: 1997-09-29