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FDA 510(k)

RayStation 6

K-Number: K170355 · 2017-03-02

Decision Date2017-03-02
Product CodeMUJ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

RayStation 6 is a medical device manufactured by RaySearch Laboratories AB (PUBL). It received FDA 510(k) clearance on 2017-03-02 under approval number K170355. The device is classified under product code MUJ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RayStation 6?

RayStation 6 is a medical device that received FDA 510(k) clearance on 2017-03-02. It is manufactured by RaySearch Laboratories AB (PUBL). The 510(k) number is K170355.

When was RayStation 6 approved by the FDA?

RayStation 6 received FDA 510(k) clearance on 2017-03-02, under approval number K170355.

What company makes RayStation 6?

RayStation 6 is manufactured by RaySearch Laboratories AB (PUBL).

What is the FDA product code for RayStation 6?

The FDA product code for RayStation 6 is MUJ.

Other Devices by RaySearch Laboratories AB (PUBL)

View all 15 devices →

Related Devices (Code: MUJ)

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.