Ziehm Solo

GUDID EZIEZIEHMSOLO1

Ziehm Imaging GmbH

Mobile general-purpose fluoroscopic x-ray system, digital

• Primary Device ID: EZIEZIEHMSOLO1
• NIH Device Record Key: 44c5f22a-1a5f-4cae-b3aa-6eaed6b70da3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ziehm Solo
• Version Model Number: 302711
• Company DUNS: 322720541
• Company Name: Ziehm Imaging GmbH
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	EZIEZIEHMSOLO1 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K092438

FDA Product Code

• OXO: Image-Intensified Fluoroscopic X-Ray System, Mobile

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-23

Devices Manufactured by Ziehm Imaging GmbH

• EZIEZIEHM80001 - Ziehm 8000: 2023-07-31 Mobile C-arm
• EZIEZIEHMVISIONFD1651 - Ziehm Vision FD: 2023-07-31 Mobile C-arm
• EZIEZIEHM8000 - Ziehm 8000: 2020-03-20
• EZIEZIEHMVISIONFD165 - Ziehm Vision FD: 2020-03-20
• EZIEZIEHMSOLO1 - Ziehm Solo: 2018-07-06
• EZIEZIEHMSOLO1 - Ziehm Solo: 2018-07-06
• EZIEZIEHMSOLOFD1 - Ziehm Solo FD: 2018-07-06
• EZIEZIEHMVISION1 - Ziehm Vision2: 2018-07-06
• EZIEZIEHMVISIONFD1 - Ziehm Vision2 FD: 2018-07-06