510(k) Report

510(k) · Cleared

Recalled · Class II · 2016

Synchrony Respiratory Tracking System

K120233510(k) TraditionalCleared Mar 9, 201244-day reviewClass II21 CFR 892.5050Recalls 1

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

Accuray Incorporated · IYE Accelerator, Linear, Medical

Cleared on Mar 9, 2012 after a 44-day review. The FDA summary names no predicate by number. 11 later devices descend from it. It has been recalled once.

Decided
Mar 9, 2012
Review
44 days
Class
Class II
Product code
IYE
Recalls
1
Predicates
0

11 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2012: 1 descendant cleared2013: 1 descendant cleared2018: 2 descendants cleared2016: 2 descendants cleared2015: 1 descendant cleared2017: 1 descendant cleared2019: 1 descendant cleared2022: 1 descendant cleared2025: 1 descendant cleared2010201520202025
  1. This deviceK120233 Synchrony Respiratory Tracking SystemAccuray Incorporated · 2012
  2. Descendant · cites it directly · 10 of its ownK122451 Exactrac VeroBrainlab AG · 2012 · Recalled
  3. Descendant · 2 generations on · 8 of its ownK131965 XVI R5.0Elekta Limited · 2013
  4. Descendant · 3 generations on · 4 of its ownK151561 Leksell Gamma Knife IconElekta Instrument AB · 2015 · Recalled
  5. Descendant · 4 generations on · 3 of its ownK160440 Leksell Gamma Knife IconElekta Instrument AB · 2016 · Recalled
  6. Descendant · 5 generations on · 2 of its ownK173789 Leksell Gamma Knife Perfexion, Leksell Gamma Knife IconElekta Instrument AB · 2018

Showing 5 of 11 descendants. See all descendants

Descendants cleared per year

2012: 12013: 12015: 12016: 22017: 12018: 22019: 12022: 12025: 1
2012high 2 (2016) · low 0 (2014)2026

Most influential descendants

Showing 5 of 11 · See all
  • K122451Exactrac VeroBrainlab AG · 2012 · cites it directly10descendants
  • K131965XVI R5.0Elekta Limited · 2013 · 2 generations on8descendants
  • K151561Leksell Gamma Knife IconElekta Instrument AB · 2015 · 3 generations on4descendants
  • K160440Leksell Gamma Knife IconElekta Instrument AB · 2016 · 4 generations on3descendants
  • K173789Leksell Gamma Knife Perfexion, Leksell Gamma Knife IconElekta Instrument AB · 2018 · 5 generations on2descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K120233Synchrony Respiratory Tracking SystemAccuray Incorporated2012—
+1K122451Exactrac VeroBrainlab AG20122
+2K131965XVI R5.0Elekta Limited2013—
+3K151561Leksell Gamma Knife IconElekta Instrument AB20151
+4K160440Leksell Gamma Knife IconElekta Instrument AB20161
+5K173789Leksell Gamma Knife Perfexion, Leksell Gamma Knife IconElekta Instrument AB2018—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201210
201310
201510
201620
201710
201820
201910
202210
202510
FIG. 1 — Lineage of K120233, 2012–2025Source: FDA 510(k) summaries, read by 510(k) Report · 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? (11)

See all 11

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K122451Exactrac VeroBrainlab AG201210

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

Recalls of this device

DateClassRecallRoot causeReason
Jan 22, 2016Class IIZ-0771-2016Device DesignThe gun box mounting bracket may fail to support the weight of the gun box when in vertical (inverted) position. If this failure occurs the gun box may become loose and could come into contact with a patient.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K122451 (Brainlab AG, 2012) has gone furthest, with 10 descendants of its own.

How does its category compare?

All IYE devices

IYE Accelerator, Linear, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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 Synchranyo Respiratory Tracking System provides an option to the CyberKnife Robotic Radiosurgery System and CyberKnife VSI Robotic Radiosurgery System that enables dynamic image-guided stereotactic radiosurgery and precision radiotherapy of lesions, tumors and conditions that move under the influence of respiration.

Indications for use as stated in the FDA summary.

More from Accuray Incorporated

21 FDA decisions under this applicant name. See the company

  • K223159Radixact Treatment Delivery SystemAccuray Incorporated · 2023
  • K212794Accuray Precision Treatment Planning SystemAccuray Incorporated · 2021
  • K202412ClearRT Helical kVCT for the Radixact Treatment Delivery SystemAccuray Incorporated · 2020
  • K182687Motion Tracking and Compensation Feature for the Radixact Treatment Delivery SystemAccuray Incorporated · 2018
  • K171837TomoTherapy Treatment Delivery System with iDMSAccuray Incorporated · 20171 recall

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/K120233 · printed Nov 6, 2026

Cite this page

510(k) Report. “K120233: Synchrony Respiratory Tracking System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K120233

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