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510(k) K852804

Device
MEDCYC SUPERCONDUCT ISOCEN NEUTRON THERAPY SYS
Applicant
MEDCYC. CORP.
510(k) number
K852804
Product code
IWL  
Decision
Substantially Equivalent (SESE)
Decision date
1985-10-15
Date received
1985-07-03
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#

Contact
WILLIAM R NUM,MY
Address
609 Beech St. East Lansing MI US 48823 48823

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)DeviceApplicantDecision date
K063691NEUTRON THERAPY SYSTEMNorthern Illinois Univ. Outreach2007-01-31
K812337ISOCENTRIC NEUTRON THERAPY SYSTEMSThe Cyclotron Corp.1981-10-02
K811778MODEL 4100 14 MEV NEUTRON GEN. THERAPYThe Cyclotron Corp.1981-07-23

Legacy Summary#

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FDA Review#

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