i-CAT FLX™ imaging system 08306300

GUDID EKAV083063000

V10

Imaging Sciences International

Cone beam computed tomography system, head/neck
Primary Device IDEKAV083063000
NIH Device Record Key034b7997-6db6-4b31-aa13-39ba599c5db9
Commercial Distribution StatusIn Commercial Distribution
Brand Namei-CAT FLX™ imaging system
Version Model Number0.830.6300
Catalog Number08306300
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
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
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
HIBCCEKAV083063000 [Primary]

FDA Product Code

OASX-ray, tomography, computed, dental

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-10-17

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

EKAV083065000V8
EKAV083063000V10
EKAV083060000V17

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