# K152994: Adaptivo

- Pathway: 510(k) (Traditional)
- Applicant: Aurora Technology Development, LLC
- Decided: Feb 3, 2016 after 113 days
- Product code: IYE (Accelerator, Linear, Medical)
- Device class: 2
- Regulation: 21 CFR 892.5050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K914698 (1992). 18 ancestors in all.
No later device cites it as a predicate yet.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141800: Perfraction, Sun Nuclear Corporation (2014) Summary page 7.
- K132605: Dosimetry Check Version 4 Release 1, Math Resolutions, LLC (2013) Summary page 7.
- K140660: MOBIUS3D, Mobius Medical Systems, LP (2014) Summary page 7.

## Indications for use
Adaptivo is a stand-alone software product that provides comparative dose information about the daily and cumulative dose received by a radiotherapy patient relative to their treatment plan. It is to be used by a radiation oncology licensed medical professional as a guide to provide pre-treatment plan delivery verification; to monitor daily treatments and indicate potential clinically relevant deviations from the intended plan delivery; to provide estimates of daily and cumulative dose delivered to the patient, accounting for patient position and anatomy changes; and to aid in determining whether a patient plan should be altered partway through the course of treatment in order to meet the treatment planning goals. Adaptivo is not a primary treatment planning software, and cannot be used to generate radiotherapy treatment plans.

Source page: https://510kreport.com/device/K152994
Methodology: https://510kreport.com/methodology