510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K063691Substantially Equivalent

Neutron Therapy System

Northern Illinois Univ. Outreach, Washington DC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K063691 is the FDA 510(k) clearance record for NEUTRON THERAPY SYSTEM, a class II device, cleared for Northern Illinois Univ. Outreach on under FDA product code IWL (System, Radiation Therapy, Neutron, Medical). FDA records list one 510(k) clearance for Northern Illinois Univ. Outreach. As of , FDA records show no recalls naming K063691.

Clearance record

Decision date
Received
(50 days to decision)
Product code
IWL System, Radiation Therapy, Neutron, Medical
Regulation
21 CFR 892.5300
Device class
Class II
Review panel
Radiology
Applicant
Northern Illinois Univ. Outreach 555 Thirteenth St. NW, Washington DC
510(k) summary
Summary PDF
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