# Accuray Incorporated

- Location (FDA's records): Sunnyvale, CA
- FDA decisions: 31 (1999–2023): 31 510(k) clearances
- Names in FDA's records: Accuray Incorporated (21); Accuray, Inc. (10)
- Product codes: IYE (19), MUJ (9), IWB (2), JAI (1)
- 510(k) review time since 2016: median 63 days, against 94 for FDA's reviews in the same codes and years (6 of 9 faster)
- Predicates its devices cite: 16 (12 its own); citations of its devices by later devices: 22 (12 its own)
- Recalls linked to its devices: 37 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Varian Assoc., Inc.: 1 (https://510kreport.com/company/varian-assoc)
- Math Resolutions, LLC: 1 (https://510kreport.com/company/math-resolutions)
- Varian Medical Systems, Inc.: 1 (https://510kreport.com/company/varian-medical-systems)
- Tomotherapy Incorporated: 1 (https://510kreport.com/company/tomotherapy)

## Firms that cite its devices most
- Varian Medical Systems, Inc.: 2 (https://510kreport.com/company/varian-medical-systems)
- Zap Surgical Systems, Inc.: 1 (https://510kreport.com/company/zap-surgical-systems)
- Brainlab AG: 1 (https://510kreport.com/company/brainlab)
- Forte Automation Systems, Inc.: 1 (https://510kreport.com/company/forte-automation-systems)
- Siemens Medical Solutions USA, Inc.: 1 (https://510kreport.com/company/siemens-medical-solutions-usa)
- Reflexion Medical, Inc.: 1 (https://510kreport.com/company/reflexion-medical)
- Diversilabs, LLC: 1 (https://510kreport.com/company/diversilabs)
- Accuray Incorportaed: 1 (https://510kreport.com/company/accuray-incorportaed)

## Its most-cited devices
- K121934: Tomotherapy Treatment System (2012), cited by 5
- K150873: CyberKnife M6 FI Sytem, CyberKnife M6 FM System, CyberKnife M6 FIM System (2015), cited by 4
- K161146: Radixact Treatment Delivery System (2016), cited by 2
- K161136: Precision Treatment Planning System (2016), cited by 1
- K041315: Cyberknife System for Stereotactic Radiosurgery/Radiotherapy (2004), cited by 1
- K102650: Cyberknife Robotic Radiosurgery System (2010), cited by 1

## Recent decisions
- K223159: Radixact Treatment Delivery System (Jun 23, 2023)
- K212794: Accuray Precision Treatment Planning System (Sep 30, 2021)
- K202412: ClearRT Helical kVCT for the Radixact Treatment Delivery System (Dec 18, 2020)
- K182687: Motion Tracking and Compensation Feature for the Radixact Treatment Delivery System (Nov 23, 2018)
- K171837: TomoTherapy Treatment Delivery System with iDMS (Jul 25, 2017)
- K171086: Accuray Precision Treatment Planning System (Jun 8, 2017)
- K161136: Precision Treatment Planning System (Jun 24, 2016)
- K161144: iDMS Data Management System (Jun 24, 2016)

Source page: https://510kreport.com/company/accuray