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510(k) K231612

Eve Patient Positioner System by Leo Cancer Care — Product Code JAI

K231612 is an FDA 510(k) premarket notification submitted by Leo Cancer Care for the device "Eve Patient Positioner System". The FDA issued a decision of Substantially Equivalent on May 7, 2024. The device falls under product code JAI (Couch, Radiation Therapy, Powered), a Class II device regulated under 21 CFR 892.5770. Leo Cancer Care has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 7, 2024
Date Received
June 2, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Couch, Radiation Therapy, Powered
Device Class
Class II
Regulation Number
892.5770
Review Panel
RA
Submission Type

Other clearances by Leo Cancer Care

  • K250970 — Marie (July 25, 2025)

Other clearances for product code JAI

  • K182683 — Z-Robot Patient Positioning System (June 27, 2019)
  • K170502 — Patient Positioning System (April 13, 2017)
  • K160518 — LEONI ORION System (July 14, 2016)
  • K132084 — PROTURA COUCH SOFTWARE (September 26, 2013)
  • K122413 — PATIENT POSITIONING SYSTEM (September 13, 2012)
  • K122201 — PROTURA COUCH SOFTWARE (August 30, 2012)
  • K120520 — EXACTRAC ROBOTICS NOVALIS ROBOTICS (June 29, 2012)
  • K120916 — QFIX RADIOTHERAPY CHAIR (June 20, 2012)
  • K072898 — HEXAPOD EVO RT COUCH TOP (October 25, 2007)
  • K071870 — HEXAPOD RT COUCH TOP (July 8, 2007)

FDA data resources