Product code IWL— Radiology

FDA has cleared 4 devices under product code IWL between 1981 and 2007, filed by 3 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

• 20071 clearance
• 19851 clearance
• 19812 clearances

• The Cyclotron Corp.2 clearances
• Northern Illinois Univ. Outreach1 clearance
• Medcyc. Corp.1 clearance

• K063691 — NEUTRON THERAPY SYSTEMNorthern Illinois Univ. Outreach·2007-01-31
• K852804 — MEDCYC SUPERCONDUCT ISOCEN NEUTRON THERAPY SYSMedcyc. Corp.·1985-10-15
• K812337 — ISOCENTRIC NEUTRON THERAPY SYSTEMSThe Cyclotron Corp.·1981-10-02
• K811778 — MODEL 4100 14 MEV NEUTRON GEN. THERAPYThe Cyclotron Corp.·1981-07-23