HELICAT

System, X-ray, Tomography, Computed

ELSCINT, INC.

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

Pre-market Notification Details

• Device ID: K930090
• 510k Number: K930090
• Device Name: HELICAT
• Classification: System, X-ray, Tomography, Computed
• Applicant: ELSCINT, INC. 505 MAIN ST. SUITE 300 Hackensack, NJ 07601
• Contact: Rochelle M Sobel
• Correspondent: Rochelle M Sobel; ELSCINT, INC. 505 MAIN ST. SUITE 300 Hackensack, NJ 07601
• Product Code: JAK
• CFR Regulation Number: 892.1750 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1993-01-08
• Decision Date: 1993-03-19