FDA 510(k)

Raycell Mk2

K-Number: K161324 · 2016-08-12

Decision Date2016-08-12

Product CodeMOT

DecisionSubstantially Equivalent

Device Summary

Raycell Mk2 is the device name listed in this FDA 510(k) record. The listed applicant is Best Theratronics Limited. It received FDA 510(k) clearance on 2016-08-12 under 510(k) number K161324. The device is classified under product code MOT. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Raycell Mk2?

Raycell Mk2 is a medical device that received FDA 510(k) clearance on 2016-08-12. The listed applicant is Best Theratronics Limited. The 510(k) number is K161324.

When did Raycell Mk2 receive FDA 510(k) clearance?

Raycell Mk2 received FDA 510(k) clearance on 2016-08-12, under 510(k) number K161324.

Who is the listed applicant for Raycell Mk2?

The FDA 510(k) record lists Best Theratronics Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Raycell Mk2?

The FDA product code for Raycell Mk2 is MOT.

Other records listing Best Theratronics Limited as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K181737Raycell MK1

Related Devices (Code: MOT)

K201177RadGil2R3 X-Ray L.L.C K181737Raycell MK1Best Theratronics Limited K172087SANGRAYHitachi , Ltd.

Official Source

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