i-CAT Precise™ imaging system 08305000

GUDID EKAV083050000

Imaging Sciences International

Cone beam computed tomography system, head/neck

• Primary Device ID: EKAV083050000
• NIH Device Record Key: 61f943c9-5935-4d32-883c-11f8d4054590
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: i-CAT Precise™ imaging system
• Version Model Number: 0.830.5000
• Catalog Number: 08305000
• Company DUNS: 800111106
• Company Name: Imaging Sciences International
• 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
• 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
• 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
• 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
• 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	EKAV083050000 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K061284

FDA Product Code

• MUH: System,x-ray,extraoral source,digital

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-24

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