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510(k) K852804

MEDCYC SUPERCONDUCT ISOCEN NEUTRON THERAPY SYS by Medcyc. Corp. — Product Code IWL

K852804 is an FDA 510(k) premarket notification submitted by Medcyc. Corp. for the device "MEDCYC SUPERCONDUCT ISOCEN NEUTRON THERAPY SYS". The FDA issued a decision of Substantially Equivalent on October 15, 1985. The device falls under product code IWL (System, Radiation Therapy, Neutron, Medical), a Class II device regulated under 21 CFR 892.5300.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 15, 1985
Date Received
July 3, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Radiation Therapy, Neutron, Medical
Device Class
Class II
Regulation Number
892.5300
Review Panel
RA
Submission Type

Other clearances for product code IWL

  • K063691 — NEUTRON THERAPY SYSTEM (January 31, 2007)
  • K812337 — ISOCENTRIC NEUTRON THERAPY SYSTEMS (October 2, 1981)
  • K811778 — MODEL 4100 14 MEV NEUTRON GEN. THERAPY (July 23, 1981)

FDA data resources