i-CAT 17-19™ imaging system 08304000

GUDID EKAV083040000

Dental CBCTDental CBCT

Imaging Sciences International

Cone beam computed tomography system, head/neck
Primary Device IDEKAV083040000
NIH Device Record Key0727bc26-5193-4fde-b688-358248deb2ca
Commercial Distribution StatusIn Commercial Distribution
Brand Namei-CAT 17-19™ imaging system
Version Model Number0.830.4000
Catalog Number08304000
Company DUNS800111106
Company NameImaging Sciences International
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+18002053570
Emailorders@i-cat.com
Phone+18002053570
Emailorders@i-cat.com
Phone+18002053570
Emailorders@i-cat.com
Phone+18002053570
Emailorders@i-cat.com
Phone+18002053570
Emailorders@i-cat.com
Phone+18002053570
Emailorders@i-cat.com
Phone+18002053570
Emailorders@i-cat.com
Phone+18002053570
Emailorders@i-cat.com
Phone+18002053570
Emailorders@i-cat.com
Phone+18002053570
Emailorders@i-cat.com
Phone+18002053570
Emailorders@i-cat.com
Phone+18002053570
Emailorders@i-cat.com
Phone+18002053570
Emailorders@i-cat.com
Phone+18002053570
Emailorders@i-cat.com
Phone+18002053570
Emailorders@i-cat.com
Phone+18002053570
Emailorders@i-cat.com
Phone+18002053570
Emailorders@i-cat.com
Phone+18002053570
Emailorders@i-cat.com
Phone+18002053570
Emailorders@i-cat.com
Phone+18002053570
Emailorders@i-cat.com
Phone+18002053570
Emailorders@i-cat.com
Phone+18002053570
Emailorders@i-cat.com
Phone+18002053570
Emailorders@i-cat.com
Phone+18002053570
Emailorders@i-cat.com
Phone+18002053570
Emailorders@i-cat.com
Phone+18002053570
Emailorders@i-cat.com
Phone+18002053570
Emailorders@i-cat.com
Phone+18002053570
Emailorders@i-cat.com
Phone+18002053570
Emailorders@i-cat.com
Phone+18002053570
Emailorders@i-cat.com
Phone+18002053570
Emailorders@i-cat.com
Phone+18002053570
Emailorders@i-cat.com
Phone+18002053570
Emailorders@i-cat.com
Phone+18002053570
Emailorders@i-cat.com
Phone+18002053570
Emailorders@i-cat.com
Phone+18002053570
Emailorders@i-cat.com
Phone+18002053570
Emailorders@i-cat.com
Phone+18002053570
Emailorders@i-cat.com
Phone+18002053570
Emailorders@i-cat.com
Phone+18002053570
Emailorders@i-cat.com
Phone+18002053570
Emailorders@i-cat.com
Phone+18002053570
Emailorders@i-cat.com
Phone+18002053570
Emailorders@i-cat.com
Phone+18002053570
Emailorders@i-cat.com
Phone+18002053570
Emailorders@i-cat.com
Phone+18002053570
Emailorders@i-cat.com
Phone+18002053570
Emailorders@i-cat.com
Phone+18002053570
Emailorders@i-cat.com
Phone+18002053570
Emailorders@i-cat.com
Phone+18002053570
Emailorders@i-cat.com
Phone+18002053570
Emailorders@i-cat.com
Phone+18002053570
Emailorders@i-cat.com
Phone+18002053570
Emailorders@i-cat.com
Phone+18002053570
Emailorders@i-cat.com
Phone+18002053570
Emailorders@i-cat.com
Phone+18002053570
Emailorders@i-cat.com
Phone+18002053570
Emailorders@i-cat.com
Phone+18002053570
Emailorders@i-cat.com
Phone+18002053570
Emailorders@i-cat.com

Operating and Storage Conditions

Handling Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCEKAV083040000 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MUHSystem,x-ray,extraoral source,digital

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-24

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EKAV083083000 - KaVo OP 3D Vision2022-01-31 V17
EKAV085006210 - NOMAD Pro2 Packaged X-Ray System - R2022-01-31
EKAV085006220 - NOMAD Pro2 Packaged X-Ray System Black-R2022-01-31
EKAV101261800 - DEXIS Titanium Intraoral X-Ray Sensor2022-01-31
EKAV101261810 - KaVo IXS Size 1, Intra-Oral X-Ray Sensor2022-01-31
EKAV101261820 - KaVo IXS Size 2, Intra-Oral X-Ray Sensor2022-01-31

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