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510(k) K911612

NUCLETRON PLANNING SYSTEM by Nucletron-Oldelft Corp. — Product Code IYE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 13, 1991
Date Received
April 11, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Accelerator, Linear, Medical
Device Class
Class II
Regulation Number
892.5050
Review Panel
RA
Submission Type

Other clearances by Nucletron-Oldelft Corp.

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  • 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)
  • 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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