510(k) K812337

Device: Isocentric Neutron Therapy Systems
Applicant: THE CYCLOTRON CORP.
510(k) number: K812337
Product code: IWL
Decision: Substantially Equivalent (SESE)
Decision date: 1981-10-02
Date received: 1981-08-18
Regulation: 892.5300
Classification name: System, Radiation Therapy, Neutron, Medical
Medical specialty: Radiology
Review panel: Radiology
Device class: 2
Clearance type: Traditional
Third party reviewed: No

Applicant Contact#

Address: 803 N. Front St. Suite 3 Mchenry IL US 60050 60050

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code IWL#

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K063691	NEUTRON THERAPY SYSTEM	Northern Illinois Univ. Outreach	2007-01-31
K852804	MEDCYC SUPERCONDUCT ISOCEN NEUTRON THERAPY SYS	Medcyc. Corp.	1985-10-15
K811778	MODEL 4100 14 MEV NEUTRON GEN. THERAPY	The Cyclotron Corp.	1981-07-23