I2C— 510(k) K132847

Clearance details

Applicant

Ion Beam Applications S.A.

Product code

Code LHN

Device class

Class 2

Regulation

21 CFR 892.5050

Advisory panel

Radiology

Date received

2013-09-11

Decision date

2013-11-20

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Philadelphia, PA, US

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• Z-2109-2018 — 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 respect to the therapy equipment and to provide correction feedback to the radiation therapy system.Class II·Terminated·Ion Beam Applications S.A.·20161028
• Z-2138-2018 — 12CClass II·Terminated·Ion Beam Applications S.A.·20160916
• Z-0836-2015 — 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 therapy equipment and to provide correction feedback to the radiation therapy device.Class II·Terminated·Ion Beam Applications S.A.·20141107

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K132847.