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FDA Product Code

FDA Product Code IWY — Clearance Directory

Device Class
Class I
Assigned Panel
Radiology
21 CFR Citation
892.1920

510(k) Clearances — 10 records

K-Number Device Name Applicant Decision Date Clearance Type Summary
K925705 ACCURAD-200 SYSTEM & ACCURAD-300 PLUS SYSTEM Denar Corp. 1992-12-28 Traditional PDF ↗
K884493 HEAD HOLDING DEVICE/SLEEP APNEA X-Ray Systems 1989-01-12 Traditional PDF ↗
K884847 MTD HEDREST Composites Horizons, Inc. 1989-01-09 Traditional PDF ↗
K864527 DUOCEPH Gary E. Hall, Dds 1987-01-07 Traditional PDF ↗
K850197 KELLER CEPHALOMETRIC DEVICE Gary D. Keller 1985-03-22 Traditional PDF ↗
K844549 HEAD-SPINE STABILIZER HSS-1 Imaging Accessories, Inc. 1985-03-01 Traditional PDF ↗
K843340 PORTA-STAT Porta-Stat, Inc. 1984-11-27 Traditional PDF ↗
K834559 DELUXE WALL-MOUNTED CEPHALOMETER Knochen Dental Laboratory 1984-02-21 Traditional PDF ↗
K802140 LEKSELL STEREOTACTIC SYSTEM Downs Surgical , Ltd. 1981-02-05 Traditional PDF ↗
K772313 X-RAY CO-ORDINATOR Rinn Corp. 1978-01-30 Traditional PDF ↗

Product code IWY · Class I · Radiology. Data: openFDA.