Adaptivo

FDA 510(k) K152994 · Aurora Technology Development, LLC

Substantially Equivalent

510(k) numberK152994

Submission

Device name
Adaptivo
Applicant
Aurora Technology Development, LLC
Madison, WI, US
Received
October 13, 2015
Decision date
February 3, 2016
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
IYE – Accelerator, Linear, Medical
Device class
Class II (moderate risk)
Regulation
21 CFR 892.5050
Specialty
Radiology

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Questions and answers

When was Adaptivo cleared by the FDA?

Adaptivo (K152994) received a 510(k) decision of Substantially Equivalent on February 3, 2016, 113 days after the submission was received.

What is the product code of K152994?

The FDA product code is IYE – Accelerator, Linear, Medical, a Class II (moderate risk) device regulated under 21 CFR 892.5050.