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FDA 510(k)

Deep Recon

K-Number: K193073 · 2020-07-06

Decision Date2020-07-06
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Deep Recon is a medical device manufactured by Shanghai United Imaging Healthcare Co., Ltd.. It received FDA 510(k) clearance on 2020-07-06 under approval number K193073. 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 Deep Recon?

Deep Recon is a medical device that received FDA 510(k) clearance on 2020-07-06. It is manufactured by Shanghai United Imaging Healthcare Co., Ltd.. The 510(k) number is K193073.

When was Deep Recon approved by the FDA?

Deep Recon received FDA 510(k) clearance on 2020-07-06, under approval number K193073.

What company makes Deep Recon?

Deep Recon is manufactured by Shanghai United Imaging Healthcare Co., Ltd..

What is the FDA product code for Deep Recon?

The FDA product code for Deep Recon is JAK.

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Official Source

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