Accuray, Inc.: FDA filings under this applicant name
FDA lists 10 510(k) clearances under the applicant name “Accuray, Inc.” (first 1999, latest 2009), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 50 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| IYE | Accelerator, Linear, Medical | 4 | 4 |
| MUJ | System, Planning, Radiation Therapy Treatment | 4 | 4 |
| IWB | System, Radiation Therapy, Radionuclide | 2 | 2 |
Review panels
- Radiology (10)
Most recent Accuray, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K091999 | CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM | IYE | 2009-09-18 | 78 |
| K091146 | MODIFICATION TO CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM | MUJ | 2009-05-01 | 11 |
| K062967 | CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM | MUJ | 2006-10-30 | 31 |
| K051941 | CYBERNIFE STEREOTACTIC RADIOSURGERY SYSTEM | MUJ | 2005-08-09 | 22 |
| K041315 | CYBERKNIFE SYSTEM FOR STEREOTACTIC RADIOSURGERY/RADIOTHERAPY | IYE | 2004-06-10 | 24 |
| K032345 | CYBERKNIFE SYSTEM FOR STEROTACTIC RADIOSURGERY/RADIOTHERAPY | MUJ | 2003-09-03 | 35 |
| K020294 | MOTION TRACKING | IYE | 2002-04-22 | 84 |
| K011024 | CYBERKNIFE SYSTEM | IYE | 2001-08-10 | 128 |
| K000478 | THE CYBERKNIFE SYSTEM FOR STEREOTACTIC RADIOSURGERY/ RADIOTHERAPY V2.1 | IWB | 2000-04-19 | 65 |
| K984563 | THE CYBERKNIFE SYSTEM FOR STEREOTACTIC RADIOSURGERY/RADIOTHERAPY | IWB | 1999-07-14 | 203 |
Recalls
13 product recalls in 12 recall events; 0 initiated in the last five years. Most recent: 2010-10-28.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
SEC filings
ACCURAY INC (ARAY): EDGAR filings, CIK 1138723. An SEC registrant with the same name, matched by name only.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Accuray Incorporated (21 510(k)s)
- Accuray Incorportaed (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Accuray, Inc.?
FDA lists 10 510(k) clearances under the applicant name “Accuray, Inc.” (first 1999, latest 2009), across 3 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Accuray, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Accuray, Inc. is 50 days.
Which FDA product codes appear under Accuray, Inc.?
The most frequent FDA product codes under this applicant name are IYE (Accelerator, Linear, Medical, 4); MUJ (System, Planning, Radiation Therapy Treatment, 4); IWB (System, Radiation Therapy, Radionuclide, 2).
Next steps
- See all 10 Accuray, Inc. clearances with predicates and recalls
- Run predicate analysis for product code IYE, Accuray, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.