# K981112: Mobetron

- Pathway: 510(k) (Traditional)
- Applicant: Intraop Medical, Inc.
- Decided: Jul 24, 1998 after 120 days
- Product code: LHN (System, Radiation Therapy, Charged-Particle, Medical)
- Device class: 2
- Regulation: 21 CFR 892.5050
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K852907 (1985). 1 ancestor in all.
25 later devices descend from it; 3 cite it directly.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K852907: Siemens Mevatron ME, Siemens Medical Laboratories, Inc. (1985) Summary page 1.

## Most influential descendants
- K992577: Photon Radiosurgery System (PRS) (1999), 20 descendants of its own
- K051055: Intrabeam System (2005), 9 descendants of its own
- K121653: Intrabeam System with Intrabeam Spherical Applicators (2012), 8 descendants of its own
- K050843: Axxent Electronic Brachytherapy System (2005), 8 descendants of its own
- K133655: Radiance V2 (2014), 5 descendants of its own

## Recalls of this device
- Jun 20, 2008 · Not classified · Z-0014-2009: Docking screw/nut failure, which may result in a treatment head dropping, potentially impacting the patient.

## Indications for use
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.

Source page: https://510kreport.com/device/K981112
Methodology: https://510kreport.com/methodology