ZIEHM SOLO

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 Solo.

Pre-market Notification Details

• Device ID: K092438
• 510k Number: K092438
• Device Name: ZIEHM SOLO
• Classification: Interventional Fluoroscopic X-ray System
• Applicant: ZIEHM IMAGING, INC. 4181 LATHAM ST. Riverside, CA 92501
• Contact: Richard L Westrich
• Correspondent: Richard L 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: 2009-08-07
• Decision Date: 2009-12-23
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
EZIEZIEHMSOLO1	K092438	000