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510(k) K182683

Z-Robot Patient Positioning System by Chinan Biomedical Technology, Inc. — Product Code JAI

K182683 is an FDA 510(k) premarket notification submitted by Chinan Biomedical Technology, Inc. for the device "Z-Robot Patient Positioning System". The FDA issued a decision of Substantially Equivalent on June 27, 2019. The device falls under product code JAI (Couch, Radiation Therapy, Powered), a Class II device regulated under 21 CFR 892.5770.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 27, 2019
Date Received
September 26, 2018
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 for product code JAI

  • K231612 — Eve Patient Positioner System (May 7, 2024)
  • 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