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510(k) K132084

PROTURA COUCH SOFTWARE by Med-Tec, Inc. D/B/A Civco Medical Solutions — Product Code JAI

K132084 is an FDA 510(k) premarket notification submitted by Med-Tec, Inc. D/B/A Civco Medical Solutions for the device "PROTURA COUCH SOFTWARE". The FDA issued a decision of Substantially Equivalent on September 26, 2013. The device falls under product code JAI (Couch, Radiation Therapy, Powered), a Class II device regulated under 21 CFR 892.5770. Med-Tec, Inc. D/B/A Civco Medical Solutions has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 26, 2013
Date Received
July 5, 2013
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 Med-Tec, Inc. D/B/A Civco Medical Solutions

  • K122201 — PROTURA COUCH SOFTWARE (August 30, 2012)

Other clearances for product code JAI

  • K231612 — Eve Patient Positioner System (May 7, 2024)
  • K182683 — Z-Robot Patient Positioning System (June 27, 2019)
  • K170502 — Patient Positioning System (April 13, 2017)
  • K160518 — LEONI ORION System (July 14, 2016)
  • 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