510(k) Report

510(k) · Cleared

Recalled · 2012

Cyberknife Robotic Radiosurgery System

K091999510(k) SpecialCleared Sep 18, 200978-day reviewClass II21 CFR 892.5050Recalls 3

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Accuray, Inc. · IYE Accelerator, Linear, Medical

Cleared on Sep 18, 2009 after a 78-day review. The FDA summary names no predicate by number. It has been recalled 3 times.

Decided
Sep 18, 2009
Review
78 days
Class
Class II
Product code
IYE
Recalls
3
Predicates
0

The FDA summary names no predicate by number.

FIG. 1 — Lineage of K091999Source: FDA 510(k) database · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in IYE? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new IYE device

  1. #1 K252977 Halcyon, Ethos Radiotherapy System (5.0)score 18.8 · 18 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
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What was it cleared against?

The FDA summary names no predicate by number.

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Jan 16, 2012Not classifiedZ-1098-2012Software designAn anomaly was discovered during internal regression testing, where the dose information is displayed incorrectly during treatment planning during a specific workflow using the optional 4D Ray Tracing dose calculation algorithm. As a…
Nov 7, 2011Not classifiedZ-0382-2012Labeling designUser Facility reported an anomaly where inhale and exhale CT pairs used for treatment planning did not represent the same magnitude of respiration that was displayed during treatment delivery.
Oct 28, 2010Not classifiedZ-0714-2011OtherIf users modify the dose calculation box to cover just the contoured anatomy and not the entire CT volume, dosage may not be properly calculated.

No ancestor or descendant has a Class I recall.

How does its category compare?

All IYE devices

IYE Accelerator, Linear, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.

FDA decisions per year · IYE

12in 2025

2007: 232008: 142009: 202010: 232011: 112012: 282013: 182014: 202015: 202016: 212017: 232018: 212019: 192020: 202021: 192022: 122023: 182024: 92025: 122026 (partial year): 14
2007high 28 (2012) · low 9 (2024)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · IYE

170in 2025

2007: 44 days median2008: 69 days median2009: 63 days median2010: 74 days median2011: 94 days median2012: 106 days median2013: 88 days median2014: 100 days median2015: 108 days median2016: 97 days median2017: 94 days median2018: 58 days median2019: 83 days median2020: 67 days median2021: 86 days median2022: 172 days median2023: 129 days median2024: 239 days median2025: 170 days median2026 (partial year): 120 days median
2007high 239 (2024) · low 44 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · IYE

1in 2025

2007: 782008: 492009: 222010: 272011: 732012: 202013: 112014: 142015: 82016: 72017: 72018: 72019: 22020: 42021: 52022: 32023: 72024: 12025: 12026 (partial year): 4
2007high 78 (2007) · low 1 (2024)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · IYE

101in 2025

2007: 1552008: 1142009: 1742010: 2462011: 2802012: 1282013: 962014: 1242015: 1002016: 972017: 1252018: 852019: 912020: 742021: 682022: 662023: 1282024: 812025: 101
2007high 280 (2011) · low 66 (2022)2025

MAUDE reports naming product code IYE, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007234478155
2008146949114
2009206322174
2010237427246
2011119473280
20122810620128
201318881196
20142010014124
2015201088100
20162197797
201723947125
20182158785
20191983291
20202067474
20211986568
202212172366
2023181297128
20249239181
2025121701101
2026141204—

What is it indicated for?

The CyberKnife VSI TM Robotic Radiosurgery System is indicated for treatment planning and image guided stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.

Indications for use as stated in the FDA summary.

More from Accuray, Inc.

10 FDA decisions under this applicant name. See the company

  • K091146Modification to Cyberknife Robotic Radiosurgery SystemAccuray, Inc. · 20093 recalls
  • K062967Cyberknife Robotic Radiosurgery SystemAccuray, Inc. · 2006
  • K051941Cybernife Stereotactic Radiosurgery SystemAccuray, Inc. · 2005
  • K041315Cyberknife System for Stereotactic Radiosurgery/RadiotherapyAccuray, Inc. · 2004
  • K032345Cyberknife System for Sterotactic Radiosurgery/RadiotherapyAccuray, Inc. · 2003

Recent decisions in IYE

The IYE category page

  • K261865AerFrame™ Alignment Laser Box (LBV2)Stabilix, LLC · 2026
  • K261718EZFluence (RADEZ V2)Radformation, Inc. · 2026
  • K260733MRIA Radiation Therapy Information System (MRIA)Manteia Technologies Co., Ltd. · 2026
  • K261856Halcyon, Ethos Radiotherapy System (5.0)Varian Medical Systems, Inc. · 2026
  • K252937ThinkQA 3Dosisoft SA · 2026

https://510kreport.com/device/K091999 · printed Nov 6, 2026

Cite this page

510(k) Report. “K091999: Cyberknife Robotic Radiosurgery System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K091999

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Page last updated Nov 3, 2026