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510(k) K120916

QFIX RADIOTHERAPY CHAIR by Wfr/Aquaplast Corp. — Product Code JAI

K120916 is an FDA 510(k) premarket notification submitted by Wfr/Aquaplast Corp. for the device "QFIX RADIOTHERAPY CHAIR". The FDA issued a decision of Substantially Equivalent on June 20, 2012. The device falls under product code JAI (Couch, Radiation Therapy, Powered), a Class II device regulated under 21 CFR 892.5770. Wfr/Aquaplast Corp. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 20, 2012
Date Received
March 27, 2012
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 Wfr/Aquaplast Corp.

  • K060671 — KVUE IGRT TREATMENT TABLE TOP, RT-4551KV, KVUE INSERTS AND ACCESSORIES, VARIOUS (May 4, 2006)
  • K032156 — ACCUFIX RADIOLUCENT PELVIS AND BELLY BOARDS, ACCUFIX CANTILEVER HEAD BOARD WITH (September 2, 2003)
  • K021124 — ACCUFIX TILTING RADIOTRANSLUCENT HEADHOLDER (July 2, 2002)
  • K973370 — AQUAPLAST PALATAL STENT (December 2, 1997)
  • K943871 — AQUAPLAST TIE DOWN DRESSING (September 30, 1994)
  • K942158 — AQUAPLAST NASAL SPLINTS, PRECUT SILVER SPLINT PATTERNS AND SPLINT KITS (July 29, 1994)
  • K935067 — AQUAPLAST (May 26, 1994)

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)
  • 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)
  • K072898 — HEXAPOD EVO RT COUCH TOP (October 25, 2007)
  • K071870 — HEXAPOD RT COUCH TOP (July 8, 2007)

FDA data resources