uCT

GUDID 00810030350040

The uCT Computed Tomography X-ray System uCT 780 is a computed tomography x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes and indicated for the whole body (including head, neck, cardiac and vascular).

UIH TECHNOLOGIES LLC

Full-body CT system Full-body CT system Full-body CT system Full-body CT system
Primary Device ID00810030350040
NIH Device Record Keybc451c42-d2a6-46ec-a8fe-d2ed56c82d08
Commercial Distribution StatusIn Commercial Distribution
Brand NameuCT
Version Model NumberuCT 780
Company DUNS117116896
Company NameUIH TECHNOLOGIES LLC
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 Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100810030350040 [Primary]
GS100810030350040 [Primary]
GS100810030350040 [Primary]
GS100810030350040 [Primary]

FDA Product Code

JAKSystem, X-Ray, Tomography, Computed
JAKSystem, X-Ray, Tomography, Computed
JAKSystem, X-Ray, Tomography, Computed
JAKSystem, X-Ray, Tomography, Computed

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-05-21
Device Publish Date2020-05-13

On-Brand Devices [uCT]

00810030350033The uCT Computed Tomography X-ray System uCT 760 is a computed tomography x-ray system intended
00810030350040The uCT Computed Tomography X-ray System uCT 780 is a computed tomography x-ray system intended

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.