510(k) · Cleared
Recalled · Class II · 2018True Beam, True Beam STX, Edge
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Varian Medical Systems, Inc. · IYE Accelerator, Linear, Medical
Cleared on Sep 5, 2014 as substantially equivalent to K123291 (Varian Medical Systems, Inc., 2012) and 2 other predicates after a 185-day review. Its family tree reaches back 8 generations to 1995. 31 later devices descend from it. It has been recalled 2 times.
- Decided
- Sep 5, 2014
- Review
- 185 days
- Class
- Class II
- Product code
- IYE
- Recalls
- 2
- Predicates
- 3
Its longest line of descent runs back 8 generations to K926449 (1995). 32 ancestors in all, the oldest K864886 (1987). 31 later devices descend from it, 2 citing it directly.
- Root · 8 generations backK926449 Varian Multileaf Collimator, Release 4.0Varian Assoc., Inc. · 1995
- 7 generations backK973889 Varian Multileaf Collimator with Dynamic Arc Therapy FeatureVarian Medical Systems, Inc. · 1997
- 6 generations backK990085 Millennium MLC -120Varian Assoc., Inc. · 1999 · Recalled
- 5 generations backK050442 Millennium Multi-Leaf CollimatorVarian Medical Systems · 2005 · Recalled
- 4 generations backK071992 High-Definition 120 Multileaf Collimator (HD120 MLC)Varian Medical Systems · 2007 · Recalled
- 3 generations backK092871 Trilogy MXVarian Medical Systems, Inc. · 2009 · Recalled
- 2 generations backK111106 TruebeamVarian Medical Systems, Inc. · 2011 · Recalled
- 1 generation backK123291 TruebeamVarian Medical Systems, Inc. · 2012
- This deviceK140528 True Beam, True Beam STX, EdgeVarian Medical Systems, Inc. · 2014
- Descendant · cites it directly · 25 of its ownK143224 TrueBeam-TrueBeam STx-EdgeVarian Medical Systems, Inc. · 2014 · Recalled
- Descendant · 2 generations on · 23 of its ownK162472 TrueBeam-TrueBeam STx-EdgeVarian Medical Systems, Inc. · 2017
- Descendant · 3 generations on · 15 of its ownK170817 HalcyonVarian Medical Systems, Inc. · 2017
- Descendant · 4 generations on · 14 of its ownK181032 HalcyonVarian Medical Systems, Inc. · 2018
- Descendant · 5 generations on · 9 of its ownK192377 Ethos Treatment Management, Ethos Treatment Planning, Ethos…Varian Medical Systems, Inc. · 2020
Showing 5 of 31 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 31 · See all- K143224TrueBeam-TrueBeam STx-EdgeVarian Medical Systems, Inc. · 2014 · cites it directly25descendants
- K162472TrueBeam-TrueBeam STx-EdgeVarian Medical Systems, Inc. · 2017 · 2 generations on23descendants
- K170817HalcyonVarian Medical Systems, Inc. · 2017 · 3 generations on15descendants
- K181032HalcyonVarian Medical Systems, Inc. · 2018 · 4 generations on14descendants
- K192377Ethos Treatment Management, Ethos Treatment Planning, Ethos Radiotherapy System, HalcyonVarian Medical Systems, Inc. · 2020 · 5 generations on9descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K926449 | Varian Multileaf Collimator, Release 4.0 | Varian Assoc., Inc. | 1995 | — |
| −7 | K973889 | Varian Multileaf Collimator with Dynamic Arc Therapy Feature | Varian Medical Systems, Inc. | 1997 | — |
| −6 | K990085 | Millennium MLC -120 | Varian Assoc., Inc. | 1999 | 2 |
| −5 | K050442 | Millennium Multi-Leaf Collimator | Varian Medical Systems | 2005 | 2 |
| −4 | K071992 | High-Definition 120 Multileaf Collimator (HD120 MLC) | Varian Medical Systems | 2007 | 4 |
| −3 | K092871 | Trilogy MX | Varian Medical Systems, Inc. | 2009 | 5 |
| −2 | K111106 | Truebeam | Varian Medical Systems, Inc. | 2011 | 5 |
| −1 | K123291 | Truebeam | Varian Medical Systems, Inc. | 2012 | — |
| 0 (this device) | K140528 | True Beam, True Beam STX, Edge | Varian Medical Systems, Inc. | 2014 | — |
| +1 | K143224 | TrueBeam-TrueBeam STx-Edge | Varian Medical Systems, Inc. | 2014 | 1 |
| +2 | K162472 | TrueBeam-TrueBeam STx-Edge | Varian Medical Systems, Inc. | 2017 | — |
| +3 | K170817 | Halcyon | Varian Medical Systems, Inc. | 2017 | — |
| +4 | K181032 | Halcyon | Varian Medical Systems, Inc. | 2018 | — |
| +5 | K192377 | Ethos Treatment Management, Ethos Treatment Planning, Ethos Radiotherapy… | Varian Medical Systems, Inc. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1991 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 3 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 2 | 0 |
| 2008 | 2 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 4 | 0 |
| 2018 | 2 | 0 |
| 2020 | 2 | 0 |
| 2021 | 3 | 0 |
| 2022 | 2 | 0 |
| 2023 | 7 | 0 |
| 2024 | 2 | 0 |
| 2025 | 2 | 0 |
| 2026 | 3 | 0 |
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 K252977 Halcyon, Ethos Radiotherapy System (5.0)score 18.8 · 18 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K123291 | TruebeamSummary page 5…I Product Code: IYE Common/Usual Name: Medical linear accelerator Predicate Devices: TrueBeam Radiotherapy System and Accessories: K123291 CyberKnife Robotic Radiosurgery System and CyberKnife VSI Systems: K102650… | 2012 |
| * | K102650 | Cyberknife Robotic Radiosurgery SystemSummary page 5…rueBeam Radiotherapy System and Accessories: K123291 CyberKnife Robotic Radiosurgery System and CyberKnife VSI Systems: K102650 Agility™ K123808 Device Description: The TrueBeam™ and Edge™ Radiotherapy Delivery Systems are med… | 2010 |
| * | K123808 | AgilitySummary page 5…s: K123291 CyberKnife Robotic Radiosurgery System and CyberKnife VSI Systems: K102650 Agility™ K123808 Device Description: The TrueBeam™ and Edge™ Radiotherapy Delivery Systems are medical linear accel… | 2013 |
What descends from it? (31)
See all 312 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 20, 2018 | Class II | Z-0004-2019 | Software design | Reports have been received of an anomaly that can result in a treatment without intended gating (respiratory tracking/monitoring). This issue occurs when a patient planned with gating is treated on more than one system. |
| Jun 30, 2016 | Class II | Z-2668-2016 | Other | Vision RT Ltd received three (3) reports from different sites that discovered the following issue, unintended changes were made to planned couch parameters, specifically the couch rotation parameter, during patient set-up for the Optical… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 19 years and passes through 3 companies; a new generation was cleared every 2.3 years on median.
- 24 of the 32 ancestors have a recall of any class.
- Of its descendants, K143224 (Varian Medical Systems, Inc., 2014) has gone furthest, with 25 descendants of its own.
- 1 other device also cites its predicate K123291.
How does its category compare?
All IYE devicesIYE Accelerator, Linear, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · IYE
12in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IYE
170in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IYE
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IYE
101in 2025
MAUDE reports naming product code IYE, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 23 | 44 | 78 | 155 |
| 2008 | 14 | 69 | 49 | 114 |
| 2009 | 20 | 63 | 22 | 174 |
| 2010 | 23 | 74 | 27 | 246 |
| 2011 | 11 | 94 | 73 | 280 |
| 2012 | 28 | 106 | 20 | 128 |
| 2013 | 18 | 88 | 11 | 96 |
| 2014 | 20 | 100 | 14 | 124 |
| 2015 | 20 | 108 | 8 | 100 |
| 2016 | 21 | 97 | 7 | 97 |
| 2017 | 23 | 94 | 7 | 125 |
| 2018 | 21 | 58 | 7 | 85 |
| 2019 | 19 | 83 | 2 | 91 |
| 2020 | 20 | 67 | 4 | 74 |
| 2021 | 19 | 86 | 5 | 68 |
| 2022 | 12 | 172 | 3 | 66 |
| 2023 | 18 | 129 | 7 | 128 |
| 2024 | 9 | 239 | 1 | 81 |
| 2025 | 12 | 170 | 1 | 101 |
| 2026 | 14 | 120 | 4 | — |
What is it indicated for?
The TrueBeam and Edge Systems are intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body where radiation therapy is indicated for adults and pediatric patients. The TrueBeam and Edge Systems may be used in the delivery of radiation for treatment that includes: brain and spine tumors (such as glioma, meningioma, craniopharyngioma, pituitary tumors, spinal cord tumors…
Read the full statement (221 words)
The TrueBeam and Edge Systems are intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body where radiation therapy is indicated for adults and pediatric patients.
The TrueBeam and Edge Systems may be used in the delivery of radiation for treatment that includes: brain and spine tumors (such as glioma, meningioma, craniopharyngioma, pituitary tumors, spinal cord tumors, hemangioblastoma, orbital tumors, ocular tumors, optic nerve tumors, and skull based tumors), head and neck tumors (such as unknown primary of the head and neck, oral cavity, hypopharynx, larynx, oropharynx, nasopharynx, sinonasal, salivary gland, and thyroid cancer), thoracic tumors (such as lung cancer, esophageal cancer, thymic tumors, and mesothelioma), gynecologic tumors (such as ovarian, cervical, endometrial, vulvar, and vaginal), gastrointestinal tumors (such as gastric, pancreatic, hepatobiliary, colon, rectal, and anal carcinoma), genitourinary tumors (such as prostate, bladder, testicular, and kidney), breast tumors, sarcomas, lymphoid tumors (such as Hodgkin’s and non-Hodgkin’s lymphoma), skin cancers (such as squamous cell, basal cell, and melanoma), benign diseases (such as schwannoma, arteriovenous malformation, cavernous malformation, trigeminal neuralgia, chordoma, glomus tumors, and hemangiomas), metastasis (including all parts of the body such as brain, bone, liver, lung, kidney, and skin) and pediatric tumors (such as glioma, ependymoma, pituitary tumors, hemangioblastoma, craniopharyngioma, meningioma, metastasis, medulloblastoma, nasopharyngeal tumors, arteriovenous malformation, cavernous malformation and skull base tumors).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K140528 · printed Nov 5, 2026
Cite this page
510(k) Report. “K140528: True Beam, True Beam STX, Edge.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K140528
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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