i-CAT FLX™ imaging system 08306300

GUDID D090083063000

V10

Dental Imaging Technologies Corporation

Cone beam computed tomography system, head/neck

• Primary Device ID: D090083063000
• NIH Device Record Key: 0344f96e-8a74-4ca7-8070-9650dc6e41d5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: i-CAT FLX™ imaging system
• Version Model Number: 0.830.6300
• Catalog Number: 08306300
• Company DUNS: 800111106
• Company Name: Dental Imaging Technologies Corporation
• 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

Customer Support Contacts

• Phone: +18002053570
• Email: orders@i-cat.com
• Phone: +18002053570
• Email: orders@i-cat.com
• Phone: +18002053570
• Email: orders@i-cat.com
• Phone: +18002053570
• Email: orders@i-cat.com
• Phone: +18002053570
• Email: orders@i-cat.com
• Phone: +18002053570
• Email: orders@i-cat.com
• Phone: +18002053570
• Email: orders@i-cat.com
• Phone: +18002053570
• Email: orders@i-cat.com
• Phone: +18002053570
• Email: orders@i-cat.com
• Phone: +18002053570
• Email: orders@i-cat.com
• Phone: +18002053570
• Email: orders@i-cat.com
• Phone: +18002053570
• Email: orders@i-cat.com
• Phone: +18002053570
• Email: orders@i-cat.com
• Phone: +18002053570
• Email: orders@i-cat.com
• Phone: +18002053570
• Email: orders@i-cat.com
• Phone: +18002053570
• Email: orders@i-cat.com
• Phone: +18002053570
• Email: orders@i-cat.com
• Phone: +18002053570
• Email: orders@i-cat.com
• Phone: +18002053570
• Email: orders@i-cat.com
• Phone: +18002053570
• Email: orders@i-cat.com
• Phone: +18002053570
• Email: orders@i-cat.com
• Phone: +18002053570
• Email: orders@i-cat.com
• Phone: +18002053570
• Email: orders@i-cat.com
• Phone: +18002053570
• Email: orders@i-cat.com
• Phone: +18002053570
• Email: orders@i-cat.com
• Phone: +18002053570
• Email: orders@i-cat.com

Operating and Storage Conditions

• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D090083063000 [Primary]
HIBCC	EKAV083063000 [Previous]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K162085

FDA Product Code

• OAS: X-ray, tomography, computed, dental

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: 2022-03-14
• Device Publish Date: 2022-03-04

On-Brand Devices [i-CAT FLX™ imaging system]

• D090083065000: V8
• D090083063000: V10
• D090083060000: V17