FDA 510(k)

ThinkQA

K-Number: K180106 · 2018-03-13

Decision Date2018-03-13

Product CodeIYE

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

ThinkQA is the device name listed in this FDA 510(k) record. The listed applicant is Dosisoft. It received FDA 510(k) clearance on 2018-03-13 under 510(k) number K180106. 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 ThinkQA?

ThinkQA is a medical device that received FDA 510(k) clearance on 2018-03-13. The listed applicant is Dosisoft. The 510(k) number is K180106.

When did ThinkQA receive FDA 510(k) clearance?

ThinkQA received FDA 510(k) clearance on 2018-03-13, under 510(k) number K180106.

Who is the listed applicant for ThinkQA?

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 ThinkQA?

The FDA product code for ThinkQA 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)K191944MU2net K182966PLANET Onco Dose

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.