FDA 510(k)

Adaptivo

K-Number: K152994 · 2016-02-03

ApplicantAurora Technology Development, LLC

Decision Date2016-02-03

Product CodeIYE

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

Adaptivo is the device name listed in this FDA 510(k) record. The listed applicant is Aurora Technology Development, LLC. It received FDA 510(k) clearance on 2016-02-03 under 510(k) number K152994. 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 Adaptivo?

Adaptivo is a medical device that received FDA 510(k) clearance on 2016-02-03. The listed applicant is Aurora Technology Development, LLC. The 510(k) number is K152994.

When did Adaptivo receive FDA 510(k) clearance?

Adaptivo received FDA 510(k) clearance on 2016-02-03, under 510(k) number K152994.

Who is the listed applicant for Adaptivo?

The FDA 510(k) record lists Aurora Technology Development, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Adaptivo?

The FDA product code for Adaptivo is IYE.

Related Devices (Code: IYE)

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.

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.