Kavo 3D eXam™ imaging system 08300000

GUDID EKAV083000000

Dental CBCT

Imaging Sciences International

Cone beam computed tomography system, head/neck Cone beam computed tomography system, head/neck Cone beam computed tomography system, head/neck Cone beam computed tomography system, head/neck Cone beam computed tomography system, head/neck Cone beam computed tomography system, head/neck Cone beam computed tomography system, head/neck Cone beam computed tomography system, head/neck Cone beam computed tomography system, head/neck Cone beam computed tomography system, head/neck Cone beam computed tomography system, head/neck Cone beam computed tomography system, head/neck Cone beam computed tomography system, head/neck Cone beam computed tomography system, head/neck Cone beam computed tomography system, head/neck Cone beam computed tomography system, head/neck Cone beam computed tomography system, head/neck Cone beam computed tomography system, head/neck Cone beam computed tomography system, head/neck Cone beam computed tomography system, head/neck Cone beam computed tomography system, head/neck Cone beam computed tomography system, head/neck Cone beam computed tomography system, head/neck Cone beam computed tomography system, head/neck Cone beam computed tomography system, head/neck Cone beam computed tomography system, head/neck Cone beam computed tomography system, head/neck Cone beam computed tomography system, head/neck Cone beam computed tomography system, head/neck Cone beam computed tomography system, head/neck Cone beam computed tomography system, head/neck Cone beam computed tomography system, head/neck Cone beam computed tomography system, head/neck Cone beam computed tomography system, head/neck Cone beam computed tomography system, head/neck Cone beam computed tomography system, head/neck Cone beam computed tomography system, head/neck Cone beam computed tomography system, head/neck Cone beam computed tomography system, head/neck Cone beam computed tomography system, head/neck Cone beam computed tomography system, head/neck Cone beam computed tomography system, head/neck Cone beam computed tomography system, head/neck Cone beam computed tomography system, head/neck Cone beam computed tomography system, head/neck Cone beam computed tomography system, head/neck Cone beam computed tomography system, head/neck Cone beam computed tomography system, head/neck Cone beam computed tomography system, head/neck Cone beam computed tomography system, head/neck Cone beam computed tomography system, head/neck Cone beam computed tomography system, head/neck Cone beam computed tomography system, head/neck Cone beam computed tomography system, head/neck Cone beam computed tomography system, head/neck Cone beam computed tomography system, head/neck Cone beam computed tomography system, head/neck Cone beam computed tomography system, head/neck Cone beam computed tomography system, head/neck

• Primary Device ID: EKAV083000000
• NIH Device Record Key: dd07220f-eac3-483f-99d9-7ae8d5cbd7ee
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Kavo 3D eXam™ imaging system
• Version Model Number: 0.830.0000
• Catalog Number: 08300000
• 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

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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	EKAV083000000 [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

Devices Manufactured by Imaging Sciences International

• EKAV083081000 - KaVo OP 3D Vision: 2022-01-31 V8
• EKAV083082000 - KaVo OP 3D Vision: 2022-01-31 V10
• EKAV083083000 - KaVo OP 3D Vision: 2022-01-31 V17
• EKAV085006210 - NOMAD Pro2 Packaged X-Ray System - R: 2022-01-31
• EKAV085006220 - NOMAD Pro2 Packaged X-Ray System Black-R: 2022-01-31
• EKAV101261800 - DEXIS Titanium Intraoral X-Ray Sensor: 2022-01-31
• EKAV101261810 - KaVo IXS Size 1, Intra-Oral X-Ray Sensor: 2022-01-31
• EKAV101261820 - KaVo IXS Size 2, Intra-Oral X-Ray Sensor: 2022-01-31