uCT Computed Tomography X-ray System
K-Number: K172135 · 2018-03-02
Decision Date2018-03-02
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
uCT Computed Tomography X-ray System is a medical device manufactured by Shanghai United Imaging Healthcare Co., Ltd.. It received FDA 510(k) clearance on 2018-03-02 under approval number K172135. The device is classified under product code JAK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the uCT Computed Tomography X-ray System?
uCT Computed Tomography X-ray System is a medical device that received FDA 510(k) clearance on 2018-03-02. It is manufactured by Shanghai United Imaging Healthcare Co., Ltd.. The 510(k) number is K172135.
When was uCT Computed Tomography X-ray System approved by the FDA?
uCT Computed Tomography X-ray System received FDA 510(k) clearance on 2018-03-02, under approval number K172135.
What company makes uCT Computed Tomography X-ray System?
uCT Computed Tomography X-ray System is manufactured by Shanghai United Imaging Healthcare Co., Ltd..
What is the FDA product code for uCT Computed Tomography X-ray System?
The FDA product code for uCT Computed Tomography X-ray System is JAK.
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Official Source
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