# K161144: iDMS Data Management System

- Pathway: 510(k) (Traditional)
- Applicant: Accuray Incorporated
- Decided: Jun 24, 2016 after 63 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: 1 generation back to K150873 (2015). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150873: CyberKnife M6 FI Sytem, CyberKnife M6 FM System, CyberKnife M6 FIM System, Accuray Incorporated (2015) Summary page 4.

## Indications for use
The iDMS™ Data Management System is indicated for the storage, retrieval, and processing of data utilized in the practice of radiotherapy, stereotactic radiotherapy and stereotactic radiosurgery.

Source page: https://510kreport.com/device/K161144
Methodology: https://510kreport.com/methodology