Home / 510(k) Clearances / K120520

510(k) K120520

EXACTRAC ROBOTICS NOVALIS ROBOTICS by Brainlab AG — Product Code JAI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 29, 2012
Date Received
February 21, 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 Brainlab AG

  • K252476 — Viewer (5.4); Elements Viewer; Mixed Reality Viewer; Smart Layout; Elements View (October 16, 2025)
  • K252562 — Spine & Trauma Navigation Instruments (September 12, 2025)
  • K243432 — Vascular Navigation PAD 2.0; Navigation Software Vascular PAD (July 22, 2025)
  • K243142 — Cranial 4Pi Immobilization (June 23, 2025)
  • K250440 — RT Elements (4.5); (Elements) Multiple Brain Mets SRS; (Elements) Cranial SRS; (June 17, 2025)
  • K243633 — Brainlab Elements (7.0); Brainlab Elements Image Fusion (5.0); Brainlab Elements (June 13, 2025)
  • K243810 — TraumaCad Neo (1.1) (June 4, 2025)
  • K242569 — Mixed Reality Spine Navigation (May 16, 2025)
  • K243698 — Alignment System Cranial, with Alignment Software Cranial with LITT; Cirq Alignm (January 28, 2025)
  • K240431 — ExacTrac Dynamic (2.0); ExacTrac Dynamic Surface (July 24, 2024)

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)
  • K120916 — QFIX RADIOTHERAPY CHAIR (June 20, 2012)
  • K072898 — HEXAPOD EVO RT COUCH TOP (October 25, 2007)
  • K071870 — HEXAPOD RT COUCH TOP (July 8, 2007)