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FDA Product Code

FDA Product Code NCS — Clearance Directory

Device Class
Class II
Assigned Panel
Radiology
21 CFR Citation
892.1550

510(k) Clearances — 3 records

K-Number Device Name Applicant Decision Date Clearance Type Summary
K013886 AVERA MODEL DEI SYSTEM (DIFFRACTIVE ENERGY IMAGING SYSTEM) Advanced Diagnostics, Inc. 2002-05-10 Traditional PDF ↗
K013291 ALTAIR MODEL, DEI SYSTEM (DIFFRACTIVE ENERGY IMAGING SYSTEM) Advanced Diagnostics, Inc. 2001-11-14 Traditional PDF ↗
K001510 OS-2000 OPTICAL SONOGRAPHY SYSTEM Advanced Diagnostics, Inc. 2000-11-30 Traditional PDF ↗

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