# K132847: I2C

- Pathway: 510(k) (Traditional)
- Applicant: Ion Beam Applications S.A.
- Decided: Nov 20, 2013 after 70 days
- Product code: LHN (System, Radiation Therapy, Charged-Particle, Medical)
- Device class: 2
- Regulation: 21 CFR 892.5050
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K803130 (1981). 31 ancestors in all.
No later device cites it as a predicate yet.
0 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080742: Verisuite 1.6, Verisuite-Particle 1.6, Medcom GmbH (2008) Summary page 2.
- K072046: Exactrac 3RD Party, Exactrac X-Ray 6D 3RD Party, Exactrac Oem, Brainlab AG (2007) Summary page 2.
- K040192: ON-Board Imager Device, Varian Medical Systems, Inc. (2004) Summary page 2.
- K042720: ON-Board Imager Device, Varian Medical Systems (2004) Summary page 2.

## Recalls of this device
- Oct 28, 2016 · Class II · Z-2109-2018: 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: 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: 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 offse

## Indications for use
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.

Source page: https://510kreport.com/device/K132847
Methodology: https://510kreport.com/methodology