510(k) · Cleared
Recalled · Class II · 2016I2C
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ion Beam Applications S.A. · LHN System, Radiation Therapy, Charged-Particle, Medical
Cleared on Nov 20, 2013 as substantially equivalent to K080742 (Medcom GmbH, 2008) and 3 other predicates after a 70-day review. Its family tree reaches back 6 generations to 1981. It has been recalled 3 times.
- Decided
- Nov 20, 2013
- Review
- 70 days
- Class
- Class II
- Product code
- LHN
- Recalls
- 3
- Predicates
- 4
Its longest line of descent runs back 6 generations to K803130 (1981). 31 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backK803130 Multix U. Bucky Table X-Ray UnitSiemens Corp. · 1981 · Recalled
- 5 generations backK971452 Multix Top/Pro Radiographic X-Ray TableSiemens Medical Solutions USA, Inc. · 1997 · Recalled
- 4 generations backK983732 Thorax FD and Multix FDSiemens Medical Solutions USA, Inc. · 1999 · Recalled
- 3 generations backK992794 Stingray DR, Model 1Infimed, Inc. · 1999
- 2 generations backK024147 Paxscan 4030 Medical Digital Imaging SystemVarian Medical Systems, Inc. · 2003
- 1 generation backK080742 Verisuite 1.6, Verisuite-Particle 1.6Medcom GmbH · 2008
- This deviceK132847 I2CIon Beam Applications S.A. · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K803130 | Multix U. Bucky Table X-Ray Unit | Siemens Corp. | 1981 | 1 |
| −5 | K971452 | Multix Top/Pro Radiographic X-Ray Table | Siemens Medical Solutions USA, Inc. | 1997 | 8 |
| −4 | K983732 | Thorax FD and Multix FD | Siemens Medical Solutions USA, Inc. | 1999 | 1 |
| −3 | K992794 | Stingray DR, Model 1 | Infimed, Inc. | 1999 | — |
| −2 | K024147 | Paxscan 4030 Medical Digital Imaging System | Varian Medical Systems, Inc. | 2003 | — |
| −1 | K080742 | Verisuite 1.6, Verisuite-Particle 1.6 | Medcom GmbH | 2008 | — |
| 0 (this device) | K132847 | I2C | Ion Beam Applications S.A. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1987 | 1 | 0 |
| 1988 | 1 | 0 |
| 1992 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 3 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 3 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2003 | 2 | 0 |
| 2004 | 3 | 0 |
| 2007 | 2 | 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? (4)
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 |
|---|---|---|---|
| * | K080742 | Verisuite 1.6, Verisuite-Particle 1.6Summary page 2…verification and correction of the patient's position during a Verisuite radiotherapy treatment with external beams or charged particles. It is (K080742, Medcom) based on stereoscopic X-ray images and DRRs calculated from a CT image series of the treatme… | 2008 |
| * | K072046 | Exactrac 3RD Party, Exactrac X-Ray 6D 3RD Party, Exactrac OemSummary page 2…linear accelerator for analyzing the current patient position and ExacTrac 3rd Party calculating - when applicable - a necessary correction shift. The (K072046, Brainlab) correction shift is then exported to the MHI-TM2000 linear accelerator. The… | 2007 |
| * | K040192 | ON-Board Imager DeviceSummary page 2…ect the patient position before Iand during treatment. 0BI The On-Board Imager device is used for verification of correct patient (K040192 & position in relation to isocenter and verification of the treatment fields K042720, Varian) in relation to an… | 2004 |
| * | K042720 | ON-Board Imager DeviceSummary page 2…The On-Board Imager device is used for verification of correct patient (K040192 & position in relation to isocenter and verification of the treatment fields K042720, Varian) in relation to anatomical and/or fidlucial landmarks Indication for Use of the device 120 is used with a charg… | 2004 |
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
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 28, 2016 | Class II | Z-2109-2018 | Software change control | IBA is initiating this recall to address an issue identified with AdaPTinsight software and to reduce risk related to this problem. |
| Sep 16, 2016 | Class II | Z-2138-2018 | Finished device change control | IBA is initiating this recall to notify its customers that the use of non-IBA accessories and/or third party equipment or unauthorized modifications to an IBA medical device may pose a safety risk. |
| Nov 7, 2014 | Class II | Z-0836-2015 | Software design (manufacturing process) | Two issues were identified: 1. In the release of adaPT insight v1.3.2., the kV/kV Single Source acquisition workflow was linked to a wrong geometrical calibration file, resulting in an alignment offset for this specific mode of… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 32 years and passes through 6 companies; a new generation was cleared every 5.2 years on median.
- 15 of the 31 ancestors have a recall of any class.
- 1 other device also cites its predicate K080742.
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. 2013, 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?
12C is used with a charged particle or photon radiation therapy system for localization of the patient position with respect to the therapy equipment and to provide correction feedback to the radiation therapy device.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K132847 · printed Nov 5, 2026
Cite this page
510(k) Report. “K132847: I2C.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K132847
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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