Zenition 30 718076

GUDID 00884838094932

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

Philips Medical Systems Nederland B.V.

Mobile general-purpose fluoroscopic x-ray system, digital Mobile general-purpose fluoroscopic x-ray system, digital Mobile general-purpose fluoroscopic x-ray system, digital Mobile general-purpose fluoroscopic x-ray system, digital Mobile general-purpose fluoroscopic x-ray system, digital Mobile general-purpose fluoroscopic x-ray system, digital Mobile general-purpose fluoroscopic x-ray system, digital Mobile general-purpose fluoroscopic x-ray system, digital Mobile general-purpose fluoroscopic x-ray system, digital Mobile general-purpose fluoroscopic x-ray system, digital Mobile general-purpose fluoroscopic x-ray system, digital

• Primary Device ID: 00884838094932
• NIH Device Record Key: 025a18eb-5016-4914-b260-427e60510978
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Zenition 30
• Version Model Number: Zenition 30
• Catalog Number: 718076
• Company DUNS: 413819707
• Company Name: Philips Medical Systems Nederland B.V.
• 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: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Handling Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00884838094932 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K232420

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-05-01
• Device Publish Date: 2024-04-23

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