FDA 510(k)

MU2net

K-Number: K191944 · 2019-10-24

Decision Date2019-10-24

Product CodeIYE

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

MU2net is the device name listed in this FDA 510(k) record. The listed applicant is Dosisoft. It received FDA 510(k) clearance on 2019-10-24 under 510(k) number K191944. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MU2net?

MU2net is a medical device that received FDA 510(k) clearance on 2019-10-24. The listed applicant is Dosisoft. The 510(k) number is K191944.

When did MU2net receive FDA 510(k) clearance?

MU2net received FDA 510(k) clearance on 2019-10-24, under 510(k) number K191944.

Who is the listed applicant for MU2net?

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

What is the FDA product code for MU2net?

The FDA product code for MU2net is IYE.

Other records listing Dosisoft 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.

K252937ThinkQA 3 K241765PLANET Onco Dose (3.2)K231573ThinkQA (Edition 2)K182966PLANET Onco Dose K180106ThinkQA

Related Devices (Code: IYE)

K261856Halcyon, Ethos Radiotherapy System (5.0)Varian Medical Systems, Inc.K252937ThinkQA 3Dosisoft SA K253004LUNA 3DLap GmbH Laser Applikationen K260792AerFrame Patient Immobilization System (AFPIS)Stabilix, LLC K252258VERIQA RT EPID 3DPtw-Freiburg Physikalisch-Technische-Werkstaetten Dr. Pychla K253962ClearCheck (RADCC V2.7)Radformation, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.