Product code IYW— Radiology

FDA has cleared 4 devices under product code IYW between 1978 and 1995, 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.

• 19951 clearance
• 19901 clearance
• 19881 clearance
• 19781 clearance

• Union Carbide Corp.1 clearance
• Mse Medizintechnik GmbH & Co. KG1 clearance
• Medical and Scientific Enterprises, Inc.1 clearance
• Atomic Products Corp.1 clearance

• K944684 — POLYSCAN DIGITAL SCANNERMse Medizintechnik GmbH & Co. KG·1995-05-15
• K895799 — RECTILINEAR SCANNER MODEL #187-270Atomic Products Corp.·1990-02-01
• K882453 — POLYSCAN DIGITAL SCANNERMedical and Scientific Enterprises, Inc.·1988-11-23
• K780395 — IMAGER, BODY SECTION, RADIONUCLIDEUnion Carbide Corp.·1978-03-31