Eve Patient Positioner System— 510(k) K231612

Substantially Equivalent

Leo Cancer Care

FDA 510(k) clearance K231612 for Eve Patient Positioner System, Substantially Equivalent on 2024-05-07. Applicant: Leo Cancer Care. Device class: 2.

Clearance details

Applicant: Leo Cancer Care
Product code: Code JAI
Device class: Class 2
Regulation: 21 CFR 892.5770
Advisory panel: Radiology
Date received: 2023-06-02
Decision date: 2024-05-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Middleton, WI, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JAI

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K170502 — Patient Positioning System2017-04-13
K160518 — LEONI ORION System2016-07-14
K132084 — PROTURA COUCH SOFTWARE2013-09-26
K122413 — PATIENT POSITIONING SYSTEM2012-09-13

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Data sourced from openFDA. This site is unofficial and independent of the FDA.