i-CAT FLX™ imaging system 08306300

GUDID D090083063000

V10

Dental Imaging Technologies Corporation

Cone beam computed tomography system, head/neck
Primary Device IDD090083063000
NIH Device Record Key0344f96e-8a74-4ca7-8070-9650dc6e41d5
Commercial Distribution StatusIn Commercial Distribution
Brand Namei-CAT FLX™ imaging system
Version Model Number0.830.6300
Catalog Number08306300
Company DUNS800111106
Company NameDental Imaging Technologies Corporation
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

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

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCD090083063000 [Primary]
HIBCCEKAV083063000 [Previous]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OASX-ray, tomography, computed, dental

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-03-14
Device Publish Date2022-03-04

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

D090083065000V8
D090083063000V10
D090083060000V17

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.