SYSTEM, X-RAY, STATIONARY TITAN 11

GUDID 08809246620032

TITAN 11 is a diagnostic DR System that contains high output capacity and high-resolution image processing system. During a surgery, the presence of lesions, size, and location can be recorded easily as Radiography images. The important images can be stored within the device so taking Radiography images is convenient.

GEMSS MEDICAL SYSTEMS CO.,LTD.

Computed radiography digital imaging scanner

• Primary Device ID: 08809246620032
• NIH Device Record Key: ba5b5e31-e721-458c-a64e-f3e2fb537bc1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SYSTEM, X-RAY, STATIONARY
• Version Model Number: TITAN 11
• Catalog Number: TITAN 11
• Company DUNS: 689163897
• Company Name: GEMSS MEDICAL SYSTEMS CO.,LTD.
• Device Count: 1
• DM Exempt: true
• 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

Customer Support Contacts

• Phone: +82317372211
• Email: sangwoo.lee@gemss-medical.com

Operating and Storage Conditions

• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 103 KiloPascal

Device Identifiers

Device Issuing Agency	Device ID
GS1	08809246620032 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K133695

FDA Product Code

• KPR: System, X-Ray, Stationary

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2019-04-23
• Device Publish Date: 2016-09-24