Zenition 30

Basic Information

• Brand Name: Zenition 30
• Primary DI: 00884838094932
• Version / Model: Zenition 30
• Catalog Number: 718076
• Company Name: Philips Medical Systems Nederland B.V.
• Labeler DUNS: 413819707
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-04-23
• Public Version: 2
• Public Version Date: 2024-12-23
• Public Version Status: Update
• Public Device Record Key: 025a18eb-5016-4914-b260-427e60510978

Device Description

The Zenition 30 with flat detector is a mobile X-ray imaging and viewing system. It is designed for medical use in healthcare facilities where X-ray imaging is needed

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: No
• 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
OWB	Interventional Fluoroscopic X-Ray System	Radiology	892.1650	2

GMDN Terms

Code	Name	Definition	Implantable	Status
37646	Mobile general-purpose fluoroscopic x-ray system, digital	A mobile (within an imaging facility) general-purpose diagnostic fluoroscopic x-ray system that uses a C-arm and digital techniques for image capture, display and manipulation and is designed to be used in a variety of general-purpose applications requiring real-time fluoroscopic imaging capabilities. 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. Images can be both real-time and delayed formats.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00884838094932	GS1

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: -10 – 55 Degrees Celsius
• Type: Handling Environment Humidity
• Temperature Range: 20 – 90 Percent (%) Relative Humidity
• Type: Storage Environment Humidity
• Temperature Range: 20 – 90 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: -10 – 55 Degrees Celsius