Product code IWY— Radiology

FDA has cleared 10 devices under product code IWY between 1978 and 1992, filed by 10 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.

• 19921 clearance
• 19892 clearances
• 19871 clearance
• 19852 clearances
• 19842 clearances
• 19811 clearance
• 19781 clearance

• X-Ray Systems1 clearance
• Rinn Corp.1 clearance
• Porta-Stat, Inc.1 clearance
• Knochen Dental Laboratory1 clearance
• Imaging Accessories, Inc.1 clearance
• Gary E. Hall, Dds1 clearance
• Gary D. Keller1 clearance
• Downs Surgical , Ltd.1 clearance
• Denar Corp.1 clearance
• Composites Horizons, Inc.1 clearance

• K925705 — ACCURAD-200 SYSTEM & ACCURAD-300 PLUS SYSTEMDenar Corp.·1992-12-28
• K884493 — HEAD HOLDING DEVICE/SLEEP APNEAX-Ray Systems·1989-01-12
• K884847 — MTD HEDRESTComposites Horizons, Inc.·1989-01-09
• K864527 — DUOCEPHGary E. Hall, Dds·1987-01-07
• K850197 — KELLER CEPHALOMETRIC DEVICEGary D. Keller·1985-03-22
• K844549 — HEAD-SPINE STABILIZER HSS-1Imaging Accessories, Inc.·1985-03-01
• K843340 — PORTA-STATPorta-Stat, Inc.·1984-11-27
• K834559 — DELUXE WALL-MOUNTED CEPHALOMETERKnochen Dental Laboratory·1984-02-21
• K802140 — LEKSELL STEREOTACTIC SYSTEMDowns Surgical , Ltd.·1981-02-05
• K772313 — X-RAY CO-ORDINATORRinn Corp.·1978-01-30