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510(k) K812337

ISOCENTRIC NEUTRON THERAPY SYSTEMS by The Cyclotron Corp. — Product Code IWL

K812337 is an FDA 510(k) premarket notification submitted by The Cyclotron Corp. for the device "ISOCENTRIC NEUTRON THERAPY SYSTEMS". The FDA issued a decision of Substantially Equivalent on October 2, 1981. The device falls under product code IWL (System, Radiation Therapy, Neutron, Medical), a Class II device regulated under 21 CFR 892.5300. The Cyclotron Corp. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 2, 1981
Date Received
August 18, 1981
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 by The Cyclotron Corp.

  • K811778 — MODEL 4100 14 MEV NEUTRON GEN. THERAPY (July 23, 1981)

Other clearances for product code IWL

  • K063691 — NEUTRON THERAPY SYSTEM (January 31, 2007)
  • K852804 — MEDCYC SUPERCONDUCT ISOCEN NEUTRON THERAPY SYS (October 15, 1985)
  • K811778 — MODEL 4100 14 MEV NEUTRON GEN. THERAPY (July 23, 1981)

FDA data resources