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FDA Product Code

FDA Product Code IWA — Clearance Directory

Device Class
Class II
Assigned Panel
Radiology
21 CFR Citation
892.5730

510(k) Clearances — 8 records

K-Number Device Name Applicant Decision Date Clearance Type Summary
K915253 IR-192 IMPLANT, MODIFICATION Omnitron Intl., Inc. 1992-02-27 Traditional PDF ↗
K894409 CESIUM-137 MICROSEED SOURCE TRAIN ASSEMBLY/SHIELD Amersham Corp. 1989-09-29 Traditional PDF ↗
K874895 IR-192 IMPLANT Rads S.L., Inc. 1988-02-25 Traditional PDF ↗
K850382 IRIDIUM SEEDS Radiation Safety & Nuclear Products, Inc. 1985-08-15 Traditional PDF ↗
K844248 IR-192 IMPLANT Rads S.L., Inc. 1985-04-10 Traditional PDF ↗
K850726 WIRE CUTTERS, BRACHYTHERAPY-TABLE TOP & HAND HELD Syncor Intl. Corp. 1985-03-26 Traditional PDF ↗
K850163 IRIDIUM 192 WIRES Syncor Intl. Corp. 1985-03-26 Traditional PDF ↗
K771878 IRIDIUM 192 WIRES & PINS Cis Radiopharmaceuticals, Inc. 1977-10-27 Traditional PDF ↗

Product code IWA · Class II · Radiology. Data: openFDA.