510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K811778Substantially Equivalent

Model 4100 14 Mev Neutron Gen. Therapy

The Cyclotron Corp., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K811778 is the FDA 510(k) clearance record for MODEL 4100 14 MEV NEUTRON GEN. THERAPY, a class II device, cleared for The Cyclotron Corp. on under FDA product code IWL (System, Radiation Therapy, Neutron, Medical). FDA records list 2 510(k) clearances for The Cyclotron Corp., from to . As of , FDA records show no recalls naming K811778.

Clearance record

Decision date
Received
(30 days to decision)
Product code
IWL System, Radiation Therapy, Neutron, Medical
Regulation
21 CFR 892.5300
Device class
Class II
Review panel
Radiology
Applicant
The Cyclotron Corp. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code IWL

Trailing 12 months

FDA records hold no clearances under product code IWL in the trailing twelve months.

FDA records show no clearances under product code IWL in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code IWL, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260