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FDA 510(k)

RIOScan (RPS500)

K-Number: K160788 · 2016-04-15

ApplicantRay Co., Ltd.
Decision Date2016-04-15
Product CodeMUH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

RIOScan (RPS500) is a medical device manufactured by Ray Co., Ltd.. It received FDA 510(k) clearance on 2016-04-15 under approval number K160788. The device is classified under product code MUH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RIOScan (RPS500)?

RIOScan (RPS500) is a medical device that received FDA 510(k) clearance on 2016-04-15. It is manufactured by Ray Co., Ltd.. The 510(k) number is K160788.

When was RIOScan (RPS500) approved by the FDA?

RIOScan (RPS500) received FDA 510(k) clearance on 2016-04-15, under approval number K160788.

What company makes RIOScan (RPS500)?

RIOScan (RPS500) is manufactured by Ray Co., Ltd..

What is the FDA product code for RIOScan (RPS500)?

The FDA product code for RIOScan (RPS500) is MUH.

Other Devices by Ray Co., Ltd.

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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.

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