510(k) K132847 ยท LHN System, Radiation Therapy, Charged-Particle, Medical
I2C
| Applicant | Ion Beam Applications S.A., Philadelphia PA, US |
| Decision | Substantially Equivalent, Nov 20, 2013 |
| Received | Sep 11, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K132847
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 28, 2016 | Ion Beam Applications S.A. 12C (AdaPTinsight)
Affected component: AdaPTinsight software
Product Usage:
12C is used with a charged particle or photon radiation therapy system for localization of the patient position with respec Terminated |
LHN | None listed |
| Sep 16, 2016 | Ion Beam Applications S.A. 12C Terminated |
LHN | None listed |
| Dec 19, 2014 | Ion Beam Applications S.A. adaPT insight (12C), v1.3.2, PAT.109 (US), Treatment room 4: I2C is used with a charged particle or photon radiation therapy system for localization of the patient position with respect to the therap Terminated |
LHN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.