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510(k) K781519

EMI SIMULATOR REMOTE CONTROL CONSOLE by Emi Medical, Inc. — Product Code KPQ

K781519 is an FDA 510(k) premarket notification submitted by Emi Medical, Inc. for the device "EMI SIMULATOR REMOTE CONTROL CONSOLE". The FDA issued a decision of Substantially Equivalent on September 14, 1978. The device falls under product code KPQ (System, Simulation, Radiation Therapy), a Class II device regulated under 21 CFR 892.5840. Emi Medical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 14, 1978
Date Received
September 1, 1978
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 Emi Medical, Inc.

  • K791429 — EMISONIC 4290 (September 21, 1979)
  • K781936 — SCANNER-EMI 7020 AND 7020R (December 4, 1978)
  • K781051 — EMISONIC 4201 (July 17, 1978)
  • K780995 — COMPUTERIZED AXIAL TOMOGRAPHY (June 22, 1978)
  • K780928 — CT5137 HIGH RESOLUTION OPTION (June 14, 1978)
  • K780930 — 5543 INDEPENDENT VIEWING SYSTEM (June 14, 1978)
  • K780736 — CT 5221 DOSE REDUCING COLLIMATORS (June 2, 1978)
  • K780737 — CT BLANKETS (BOLUS MATERIAL) (June 2, 1978)
  • K771978 — CTR 100L (November 23, 1977)
  • K772125 — TOMOGRAPHIC SCANNER, COMPUTERIZED (November 21, 1977)

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