FUJIFILM Healthcare Americas Corporation 74 13 000

GUDID 08055186671096

PERSONA C HR is a mobile X-ray device used for radiological guidance and visualization during diagnostic, interventional and surgical procedures. PERSONA C HR device can be used on all patients, except pediatric patients, within the limits of the device. Examples of clinical applications could be Orthopedic surgery, General surgery, Cardiac procedures, Thoracic surgery, Vascular procedures, Pain therapy and Urological procedures.

A.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRL

Mobile general-purpose fluoroscopic x-ray system, digital

• Primary Device ID: 08055186671096
• NIH Device Record Key: 380fdc09-f0be-4d28-b95b-aa403327cffc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FUJIFILM Healthcare Americas Corporation
• Version Model Number: Persona C HR
• Catalog Number: 74 13 000
• Company DUNS: 440069847
• Company Name: A.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRL
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08055186671096 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K250282

FDA Product Code

• OWB: Interventional Fluoroscopic X-Ray System

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: 2025-07-10
• Device Publish Date: 2025-07-02

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• 08055186671096: PERSONA C HR is a mobile X-ray device used for radiological guidance and visualization during di