510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K852804Substantially Equivalent

Medcyc Superconduct Isocen Neutron Therapy Sys

Medcyc. Corp., East Lansing MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K852804 is the FDA 510(k) clearance record for MEDCYC SUPERCONDUCT ISOCEN NEUTRON THERAPY SYS, a class II device, cleared for Medcyc. Corp. on under FDA product code IWL (System, Radiation Therapy, Neutron, Medical). FDA records list one 510(k) clearance for Medcyc. Corp. As of , FDA records show no recalls naming K852804.

Clearance record

Decision date
Received
(104 days to decision)
Product code
IWL System, Radiation Therapy, Neutron, Medical
Regulation
21 CFR 892.5300
Device class
Class II
Review panel
Radiology
Applicant
Medcyc. Corp. 609 Beech St., East Lansing MI
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