TAU Model 1000-0017 Mini C-Arm

Basic Information

• Brand Name: TAU Model 1000-0017 Mini C-Arm
• Primary DI: B225100000170
• Version / Model: 1000-0017
• Company Name: Ziehm-Orthoscan, Inc.
• Labeler DUNS: 196554021
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-05-27
• Public Version: 2
• Public Version Date: 2023-08-02
• Public Version Status: Update
• Public Device Record Key: 3d6128b7-bef7-4091-9df4-e17f6b904dcf

Device Description

Image-Intensified Fluoroscopic X-Ray, Mobile

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
OXO	Image-Intensified Fluoroscopic X-Ray System, Mobile	Radiology	892.1650	2
JAA	System, X-Ray, Fluoroscopic, Image-Intensified	Radiology	892.1650	2
MQB	Solid State X-Ray Imager (Flat Panel/Digital Imager)	Radiology	892.1680	2

GMDN Terms

Code	Name	Definition	Implantable	Status
37649	Portable general-purpose fluoroscopic x-ray system, digital	A portable (moveable from one location to another, and easily reassembled) general-purpose diagnostic fluoroscopic x-ray system that uses real-time digital techniques for image capture, display and manipulation and is specifically designed to be used in a variety of general-purpose applications requiring real-time fluoroscopic imaging. It includes spot-film capabilities in addition to the fluoroscopic features and is intended to optimize the capability of users to visually and quantitatively evaluate the anatomy and physiological function of various targeted body areas in real-time. It is frequently used in conjunction with an ingested or injected x-ray contrast medium.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B225100000170	HIBCC

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K183220	000
K213113	000

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: 32 – 131 Degrees Fahrenheit
• Type: Handling Environment Temperature
• Temperature Range: 0 – 55 Degrees Celsius
• Type: Storage Environment Humidity
• Temperature Range: 10 – 100 Percent (%) Relative Humidity
• Type: Storage Environment Atmospheric Pressure
• Temperature Range: 500 – 1600 millibar