510(k) · Cleared
Recalled · 2008Mobetron
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Intraop Medical, Inc. · LHN System, Radiation Therapy, Charged-Particle, Medical
Cleared on Jul 24, 1998 as substantially equivalent to K852907 (Siemens Medical Laboratories, Inc., 1985) after a 120-day review. Its family tree reaches back 1 generation to 1985. 25 later devices descend from it. It has been recalled once.
- Decided
- Jul 24, 1998
- Review
- 120 days
- Class
- Class II
- Product code
- LHN
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K852907 (1985). 25 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK852907 Siemens Mevatron MESiemens Medical Laboratories, Inc. · 1985
- This deviceK981112 MobetronIntraop Medical, Inc. · 1998
- Descendant · cites it directly · 20 of its ownK992577 Photon Radiosurgery System (PRS)Photoelectron Corporation · 1999
- Descendant · 2 generations on · 9 of its ownK051055 Intrabeam SystemCarl Zeiss Surgical GmbH · 2005 · Recalled
- Descendant · 2 generations on · 8 of its ownK121653 Intrabeam System with Intrabeam Spherical ApplicatorsCarl Zeiss Meditec, Inc. · 2012 · Recalled
- Descendant · 2 generations on · 8 of its ownK050843 Axxent Electronic Brachytherapy SystemXoft, Inc. · 2005
- Descendant · 3 generations on · 5 of its ownK133655 Radiance V2Gmv Soluciones Globales Internet S.A.U. · 2014
Showing 5 of 25 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 25 · See all- K992577Photon Radiosurgery System (PRS)Photoelectron Corporation · 1999 · cites it directly20descendants
- K051055Intrabeam SystemCarl Zeiss Surgical GmbH · 2005 · 2 generations on9descendants
- K121653Intrabeam System with Intrabeam Spherical ApplicatorsCarl Zeiss Meditec, Inc. · 2012 · 2 generations on8descendants
- K050843Axxent Electronic Brachytherapy SystemXoft, Inc. · 2005 · 2 generations on8descendants
- K133655Radiance V2Gmv Soluciones Globales Internet S.A.U. · 2014 · 3 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K852907 | Siemens Mevatron ME | Siemens Medical Laboratories, Inc. | 1985 | — |
| 0 (this device) | K981112 | Mobetron | Intraop Medical, Inc. | 1998 | — |
| +1 | K992577 | Photon Radiosurgery System (PRS) | Photoelectron Corporation | 1999 | — |
| +2 | K051055 | Intrabeam System | Carl Zeiss Surgical GmbH | 2005 | 2 |
| +2 | K121653 | Intrabeam System with Intrabeam Spherical Applicators | Carl Zeiss Meditec, Inc. | 2012 | 2 |
| +2 | K050843 | Axxent Electronic Brachytherapy System | Xoft, Inc. | 2005 | — |
| +3 | K133655 | Radiance V2 | Gmv Soluciones Globales Internet S.A.U. | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2005 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2016 | 3 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 4 | 0 |
| 2022 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 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? (1)
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 |
|---|---|---|---|
| * | K852907 | Siemens Mevatron MESummary page 1…MOBETRON Device Classification: System, Radiation Therapy, Charged- Particle, Medical 3. Predicate Device: Siemens Mevatron ME Linear Accelerator, 510(k) Device Number K852907 4. Description of Device: The MOBETRON is a mobile electron beam accelerator designed specifically for use in the operating room… | 1985 |
What descends from it? (25)
See all 253 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 |
|---|---|---|---|---|
| Jun 20, 2008 | Not classified | Z-0014-2009 | Component design/selection | Docking screw/nut failure, which may result in a treatment head dropping, potentially impacting the patient. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- Of its descendants, K992577 (Photoelectron Corporation, 1999) has gone furthest, with 20 descendants of its own.
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.
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 Mobetron is a mobile electron linear accelerator that produces beams of electrons
used in the radiation therapy treatment of both malignant (cancer) and benign
conditions. The Mobetron has four electron beam treatment energies and a set of
electron applicators which provide a range of field sizes from 3 to 10 cm in diameter.
For delivery of electron beam radiation during a surgical procedure, known as
Intraoperative Radiation Therapy (IORT), the Mobetron system includes a sterile cap
and sterile drapes for each IORT procedure, IORT applicators, a QA system, a
surgical table extender with added support leg, and bolus material.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K981112 · printed Nov 6, 2026
Cite this page
510(k) Report. “K981112: Mobetron.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K981112
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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