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510(k) K811778

MODEL 4100 14 MEV NEUTRON GEN. THERAPY by The Cyclotron Corp. — Product Code IWL

K811778 is an FDA 510(k) premarket notification submitted by The Cyclotron Corp. for the device "MODEL 4100 14 MEV NEUTRON GEN. THERAPY". The FDA issued a decision of Substantially Equivalent on July 23, 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
July 23, 1981
Date Received
June 23, 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.

  • K812337 — ISOCENTRIC NEUTRON THERAPY SYSTEMS (October 2, 1981)

Other clearances for product code IWL

  • K063691 — NEUTRON THERAPY SYSTEM (January 31, 2007)
  • K852804 — MEDCYC SUPERCONDUCT ISOCEN NEUTRON THERAPY SYS (October 15, 1985)
  • K812337 — ISOCENTRIC NEUTRON THERAPY SYSTEMS (October 2, 1981)

FDA data resources