GLORY

System, X-ray, Mammographic

ELSCINT, INC.

The following data is part of a premarket notification filed by Elscint, Inc. with the FDA for Glory.

Pre-market Notification Details

• Device ID: K970680
• 510k Number: K970680
• Device Name: GLORY
• Classification: System, X-ray, Mammographic
• Applicant: ELSCINT, INC. 86 ORCHARD ST. Hackensack, NJ 07601
• Contact: Beny Sherer
• Correspondent: Beny Sherer; ELSCINT, INC. 86 ORCHARD ST. Hackensack, NJ 07601
• Product Code: IZH
• CFR Regulation Number: 892.1710 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1997-02-24
• Decision Date: 1997-06-20
• Summary: summary