Product code IXF— Radiology

FDA has cleared 5 devices under product code IXF between 1981 and 1987, filed by 4 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.

• 19871 clearance
• 19851 clearance
• 19842 clearances
• 19811 clearance

• Radiation Measurements, Inc.2 clearances
• Victoreen, Inc.1 clearance
• Machlett Laboratories, Inc.1 clearance
• Computerized Imaging Reference Systems, Inc.1 clearance

• K865100 — TISSUE-EQUIVALENT BREAST SIMULATORComputerized Imaging Reference Systems, Inc.·1987-01-12
• K851812 — DIGITAL SUBTRACTION ANTIOGRAPHY PHANTOM 76-700/711Victoreen, Inc.·1985-06-05
• K834481 — DOPPLER PHANTOM FLOW CONTROL SYSRadiation Measurements, Inc.·1984-01-25
• K834482 — TISSUE MIMICKING ULTRASOUND PHANTOMSRadiation Measurements, Inc.·1984-01-25
• K810254 — 1.5` FOCAL SPOT RESOLUTION PATTERNMachlett Laboratories, Inc.·1981-02-19