ZIEHM QUANTUM

Interventional Fluoroscopic X-ray System

ZIEHM IMAGING, INC.

The following data is part of a premarket notification filed by Ziehm Imaging, Inc. with the FDA for Ziehm Quantum.

Pre-market Notification Details

• Device ID: K051064
• 510k Number: K051064
• Device Name: ZIEHM QUANTUM
• Classification: Interventional Fluoroscopic X-ray System
• Applicant: ZIEHM IMAGING, INC. 4181 LATHAM ST. Riverside, CA 92501
• Contact: Richard Westrich
• Correspondent: Richard Westrich; ZIEHM IMAGING, INC. 4181 LATHAM ST. Riverside, CA 92501
• Product Code: OWB
• Subsequent Product Code: JAA
• Subsequent Product Code: OXO
• CFR Regulation Number: 892.1650 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2005-04-26
• Decision Date: 2005-05-26