uCT 530, uCT 550
K-Number: K181414 · 2018-08-14
Decision Date2018-08-14
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
uCT 530, uCT 550 is a medical device manufactured by Shanghai United Imaging Healthcare Co., Ltd.. It received FDA 510(k) clearance on 2018-08-14 under approval number K181414. 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 530, uCT 550?
uCT 530, uCT 550 is a medical device that received FDA 510(k) clearance on 2018-08-14. It is manufactured by Shanghai United Imaging Healthcare Co., Ltd.. The 510(k) number is K181414.
When was uCT 530, uCT 550 approved by the FDA?
uCT 530, uCT 550 received FDA 510(k) clearance on 2018-08-14, under approval number K181414.
What company makes uCT 530, uCT 550?
uCT 530, uCT 550 is manufactured by Shanghai United Imaging Healthcare Co., Ltd..
What is the FDA product code for uCT 530, uCT 550?
The FDA product code for uCT 530, uCT 550 is JAK.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.