myQA iON
K-Number: K201798 · 2020-07-17
ApplicantIba Dosimetry GmbH
Decision Date2020-07-17
Product CodeLHN
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
myQA iON is a medical device manufactured by Iba Dosimetry GmbH. It received FDA 510(k) clearance on 2020-07-17 under approval number K201798. The device is classified under product code LHN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the myQA iON?
myQA iON is a medical device that received FDA 510(k) clearance on 2020-07-17. It is manufactured by Iba Dosimetry GmbH. The 510(k) number is K201798.
When was myQA iON approved by the FDA?
myQA iON received FDA 510(k) clearance on 2020-07-17, under approval number K201798.
What company makes myQA iON?
myQA iON is manufactured by Iba Dosimetry GmbH.
What is the FDA product code for myQA iON?
The FDA product code for myQA iON is LHN.
Other Devices by Iba Dosimetry GmbH
Related Devices (Code: LHN)
K162246ProNova SC360 Proton Therapy SystemPronova Solutions, LLC
K160612Sumitomo Proton Therapy SystemSumitomo Heavy Industries, Ltd.
K152224Proton Therapy System - Proteus 235 (Proteus One, Proteus Plus, Proteus TK2)Ion Beam Application S.A.
K161163PROBEAT-V Proton Beam Therapy System with X-ray Limiting AccessoryHitachi , Ltd.
K160432Anzai Respiratory Gating SystemAnzai Medical Co., Ltd.
K153614PROBEAT-V and accessoriesHitachi, Ltd., Health Care Company
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.