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510(k) K894568

NEW RAD-8 TREATMENT PLANNING COMPUTER SYSTEM by Advanced Medical Systems, Inc. — Product Code KPQ

K894568 is an FDA 510(k) premarket notification submitted by Advanced Medical Systems, Inc. for the device "NEW RAD-8 TREATMENT PLANNING COMPUTER SYSTEM". The FDA issued a decision of Substantially Equivalent on January 9, 1990. The device falls under product code KPQ (System, Simulation, Radiation Therapy), a Class II device regulated under 21 CFR 892.5840. Advanced Medical Systems, Inc. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 9, 1990
Date Received
July 21, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Simulation, Radiation Therapy
Device Class
Class II
Regulation Number
892.5840
Review Panel
RA
Submission Type

Other clearances by Advanced Medical Systems, Inc.

  • K955931 — MODEL IM77 INTRAPARTUM FETAL MONITOR (MODIFICATION) (August 14, 1996)
  • K952031 — ULTRASOUND TRANSDUCER, MODEL US917 (July 18, 1995)
  • K940898 — MODEL IM77 INTRAPARTUM FETAL MONITOR (March 1, 1995)
  • K923335 — ULTRASOUND TRANSUCER, MODEL US915 -- MODIFICATION (July 22, 1994)
  • K932278 — PFM PROFESSIONAL 7000 SPIROMETER (December 17, 1993)
  • K911657 — FETAL SCALP SPIRAL ELECTRODE (July 11, 1991)
  • K902190 — FETAL PULSE DETECTOR MODEL DOP-1 (October 22, 1990)
  • K891672 — PUL-TRON 100K PROFESSIONAL SPIROMETER (June 16, 1989)
  • K880756 — MODEL PM-20A PHYSIOLOGICAL MONITOR (September 27, 1988)

Other clearances for product code KPQ

  • K132944 — ADVANTAGESIM MD MR PELVIC ORGAN AT RISK SEGMENTATION (March 14, 2014)
  • K132045 — ADVANTAGESIM MD WITH CT ATLAS-BASED CONTOURING AND RE-PLANNING OPTIONS (September 4, 2013)
  • K101038 — RAD II SIMULATOR, RAD II KV IMAGER, DUAL RAD II KV IMAGER (August 17, 2010)
  • K090706 — ONCENTRA SIMULATION 2.3 (June 15, 2009)
  • K083591 — IKOENGELO, VERSION 2 (December 29, 2008)
  • K072445 — INTEGRATED BRACHYTHERAPY UNIT - DIGITAL (September 14, 2007)
  • K061006 — IKOENGELO (June 5, 2006)
  • K052361 — SIMULIX-EVOLUTION WITH ONCENTRA CONEBEAM (October 24, 2005)
  • K052345 — ADVANTAGE SIM MD (September 14, 2005)
  • K033470 — SIMULIX EVOLUTION (February 4, 2004)

FDA data resources