CONCEPT ONE

Generator, High-voltage, X-ray, Diagnostic

INNERSCAN, INC.

The following data is part of a premarket notification filed by Innerscan, Inc. with the FDA for Concept One.

Pre-market Notification Details

• Device ID: K933777
• 510k Number: K933777
• Device Name: CONCEPT ONE
• Classification: Generator, High-voltage, X-ray, Diagnostic
• Applicant: INNERSCAN, INC. 190 SHEPARD AVE. UNIT C Wheeling, IL 60090
• Contact: Gary Fromberg
• Correspondent: Gary Fromberg; INNERSCAN, INC. 190 SHEPARD AVE. UNIT C Wheeling, IL 60090
• Product Code: IZO
• CFR Regulation Number: 892.1700 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1993-08-03
• Decision Date: 1993-12-13