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510(k) K953946

MICROSELECTRON-HDR VERSION 2 by Nucletron-Oldelft Corp. — Product Code JAQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 13, 1996
Date Received
August 21, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Applicator, Radionuclide, Remote-Controlled
Device Class
Class II
Regulation Number
892.5700
Review Panel
RA
Submission Type

Other clearances by Nucletron-Oldelft Corp.

  • K953831 — N 800 HF (September 8, 1995)
  • K925956 — MICROSELECTRON - HDR FOR MOBILE ENVIRONMENT (November 19, 1993)
  • K926407 — MODEL COLE TAB-2 TABLE W/MODEL COLE SFD-2 SPOTFILM (March 31, 1993)
  • K921991 — PLATO RADIATION THERAPY PLANNING SYSTEM (November 27, 1992)
  • K915622 — PLATO BRACHYTHERAPHY TREATMENT PLANNING SYSTEM (September 25, 1992)
  • K911612 — NUCLETRON PLANNING SYSTEM (June 13, 1991)
  • K902533 — PULSED SELECTRON (October 12, 1990)
  • K864210 — MICROSELECTRON-HDR (HIGH DOSE RATE) (November 26, 1986)
  • K853912 — MICROSELECTION INTERSTITIAL REMOTE AFTERLOAD SYS (May 21, 1986)
  • K852842 — SELECTRON HDR REMOTE AFTERLOADER (January 10, 1986)

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