510(k) · Cleared
ClearedReal Time Image Gating System for Proton Beam Therapy Systems
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hitachi, Ltd. Healthcare · LHN System, Radiation Therapy, Charged-Particle, Medical
Cleared on Dec 26, 2017 as substantially equivalent to K133914 (Medcom GmbH, 2014) and 1 other predicate after a 263-day review. Its family tree reaches back 9 generations to 1995.
- Decided
- Dec 26, 2017
- Review
- 263 days
- Class
- Class II
- Product code
- LHN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 9 generations to K926449 (1995). 59 ancestors in all, the oldest K803130 (1981). No later device cites it as a predicate yet.
- Root · 9 generations backK926449 Varian Multileaf Collimator, Release 4.0Varian Assoc., Inc. · 1995
- 5 generations between
- 3 generations backK111106 TruebeamVarian Medical Systems, Inc. · 2011 · Recalled
- 2 generations backK123291 TruebeamVarian Medical Systems, Inc. · 2012
- 1 generation backK131965 XVI R5.0Elekta Limited · 2013
- This deviceK171049 Real Time Image Gating System for Proton Beam Therapy SystemsHitachi, Ltd. Healthcare · 2017
Show all 9 generations
- Root · 9 generations backK926449 Varian Multileaf Collimator, Release 4.0Varian Assoc., Inc. · 1995
- 8 generations backK973889 Varian Multileaf Collimator with Dynamic Arc Therapy FeatureVarian Medical Systems, Inc. · 1997
- 7 generations backK990085 Millennium MLC -120Varian Assoc., Inc. · 1999 · Recalled
- 6 generations backK050442 Millennium Multi-Leaf CollimatorVarian Medical Systems · 2005 · Recalled
- 5 generations backK071992 High-Definition 120 Multileaf Collimator (HD120 MLC)Varian Medical Systems · 2007 · Recalled
- 4 generations backK092871 Trilogy MXVarian Medical Systems, Inc. · 2009 · Recalled
- 3 generations backK111106 TruebeamVarian Medical Systems, Inc. · 2011 · Recalled
- 2 generations backK123291 TruebeamVarian Medical Systems, Inc. · 2012
- 1 generation backK131965 XVI R5.0Elekta Limited · 2013
- This deviceK171049 Real Time Image Gating System for Proton Beam Therapy SystemsHitachi, Ltd. Healthcare · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K926449 | Varian Multileaf Collimator, Release 4.0 | Varian Assoc., Inc. | 1995 | — |
| −8 | K973889 | Varian Multileaf Collimator with Dynamic Arc Therapy Feature | Varian Medical Systems, Inc. | 1997 | — |
| −7 | K990085 | Millennium MLC -120 | Varian Assoc., Inc. | 1999 | 2 |
| −6 | K050442 | Millennium Multi-Leaf Collimator | Varian Medical Systems | 2005 | 2 |
| −5 | K071992 | High-Definition 120 Multileaf Collimator (HD120 MLC) | Varian Medical Systems | 2007 | 4 |
| −4 | K092871 | Trilogy MX | Varian Medical Systems, Inc. | 2009 | 5 |
| −3 | K111106 | Truebeam | Varian Medical Systems, Inc. | 2011 | 5 |
| −2 | K123291 | Truebeam | Varian Medical Systems, Inc. | 2012 | — |
| −1 | K131965 | XVI R5.0 | Elekta Limited | 2013 | — |
| 0 (this device) | K171049 | Real Time Image Gating System for Proton Beam Therapy Systems | Hitachi, Ltd. Healthcare | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1986 | 1 | 0 |
| 1987 | 1 | 0 |
| 1988 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 3 | 0 |
| 1996 | 2 | 0 |
| 1997 | 3 | 0 |
| 1998 | 3 | 0 |
| 1999 | 3 | 0 |
| 2000 | 3 | 0 |
| 2001 | 2 | 0 |
| 2003 | 4 | 0 |
| 2004 | 4 | 0 |
| 2005 | 2 | 0 |
| 2006 | 2 | 0 |
| 2007 | 4 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 2 | 0 |
| 2014 | 1 | 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 LHN? 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 LHN device
- #1 K260597 Virtue QAscore 15.4 · 12 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K133914 | Verisuite 1.8, Verisuite-Particle 1.8, Verisuite, Verisuite-ParticleSummary page 4…n Name: Medical charged-particle radiation therapy system (21 CFR 892.5050) Regulatory Class: Class II Product Code: LHN Predicate Devices K133914 MedCom GmbH’s Verisuite K131965 Elekta Ltd.’s XVI R5.0 Reference Devices K160432 Anzai Medical’s AZ-733VI… | 2014 |
| * | K131965 | XVI R5.0Summary page 4…e radiation therapy system (21 CFR 892.5050) Regulatory Class: Class II Product Code: LHN Predicate Devices K133914 MedCom GmbH’s Verisuite K131965 Elekta Ltd.’s XVI R5.0 Reference Devices K160432 Anzai Medical’s AZ-733VI… | 2013 |
| † | K160432 | Anzai Respiratory Gating System | 2016 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 22 years and passes through 5 companies; a new generation was cleared every 2.3 years on median.
- 35 of the 59 ancestors have a recall of any class.
- 1 other device also cites its predicate K133914.
How does its category compare?
All LHN devicesLHN System, Radiation Therapy, Charged-Particle, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · LHN
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LHN
190in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LHN
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LHN
11in 2025
MAUDE reports naming product code LHN, 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 | 2 | — | 2 | 0 |
| 2008 | 3 | 113 | 2 | 1 |
| 2009 | 5 | 69 | 0 | 5 |
| 2010 | 4 | 96 | 0 | 3 |
| 2011 | 1 | — | 0 | 1 |
| 2012 | 3 | 111 | 0 | 1 |
| 2013 | 3 | 70 | 0 | 1 |
| 2014 | 4 | 93 | 2 | 5 |
| 2015 | 3 | 53 | 1 | 2 |
| 2016 | 7 | 120 | 0 | 1 |
| 2017 | 4 | 173 | 5 | 7 |
| 2018 | 3 | 78 | 2 | 8 |
| 2019 | 2 | — | 0 | 3 |
| 2020 | 4 | 74 | 1 | 20 |
| 2021 | 0 | — | 1 | 24 |
| 2022 | 2 | — | 2 | 10 |
| 2023 | 2 | — | 1 | 7 |
| 2024 | 1 | — | 0 | 2 |
| 2025 | 3 | 190 | 0 | 11 |
| 2026 | 4 | 194 | 0 | — |
What is it indicated for?
The Real Time Image Gating System for Proton Beam Therapy Systems is intended for use with compatible Hitachi proton beam therapy systems and is designed to generate gating signals to deliver a proton beam when the position of a fiducial marker, which is implanted near a tumor and tracked by use of X-ray fluoroscopy, is within a given tolerance from its planned position.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K171049 · printed Nov 6, 2026
Cite this page
510(k) Report. “K171049: Real Time Image Gating System for Proton Beam Therapy Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K171049
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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