Home / 510(k) Clearances / K990071

510(k) K990071

IMAGEFUSION 2.0 by Radionics, Inc. — Product Code MUJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 8, 1999
Date Received
January 11, 1999
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Planning, Radiation Therapy Treatment
Device Class
Class II
Regulation Number
892.5050
Review Panel
RA
Submission Type

Other clearances by Radionics, Inc.

  • K030697 — RADIONICS SINGLE USE GROUND PAD (DGP-HP) (April 4, 2003)
  • K001741 — RADIONICS RF DISC CATHETER ELECTRODE SYSTEM (October 23, 2000)
  • K002773 — NEUROMAP WITH NEURO 100 (October 23, 2000)
  • K992226 — XDS EXTERNAL CSF DRAINAGE AND MONITORING SYSTEM (August 4, 2000)
  • K001950 — OPTICAL TRACKING SYSTEM (OTS) (July 26, 2000)
  • K001700 — XPLAN 2.1 (June 28, 2000)
  • K001431 — MODIFICATION TO OPTICAL TRACKING SYSTEM (OTS) (May 17, 2000)
  • K000057 — RADIONICS LUMBOPERITONEAL SHUNT (March 20, 2000)
  • K993594 — CONFORMAX MMLC VR1 (December 15, 1999)
  • K991399 — RADIONICS MICROELECTRODE KIT (September 21, 1999)

Other clearances for product code MUJ

  • K252002 — Monaco RTP System (6.3) (February 19, 2026)
  • K260308 — TrueFit Bolus (February 19, 2026)
  • K253091 — ART-Plan+ (v3.1.0) (December 23, 2025)
  • K252109 — RayStation (2024A SP3) (December 22, 2025)
  • K252863 — ClearCalc Model RADCA V2.6 (December 19, 2025)
  • K250963 — PlanOne 1 (November 20, 2025)
  • K250064 — Dose+ (1.0) (September 4, 2025)
  • K250440 — RT Elements (4.5); (Elements) Multiple Brain Mets SRS; (Elements) Cranial SRS; (June 17, 2025)
  • K242992 — RayCare (2024A SP1) (April 17, 2025)
  • K242748 — Oncospace (April 11, 2025)