Atlas FDA

NCS

3 FDA 510(k) clearances · Product code

FDA profile

Official device name
System, Imaging, Holography, Acoustic
Device class
Class II (moderate risk)
Regulation
21 CFR 892.1550
Medical specialty
Radiology
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RecordFirmDate
AVERA MODEL DEI SYSTEM (DIFFRACTIVE ENERGY IMAGING SYSTEM) (K013886)Advanced Diagnostics, Inc.2002-05-10
ALTAIR MODEL, DEI SYSTEM (DIFFRACTIVE ENERGY IMAGING SYSTEM) (K013291)Advanced Diagnostics, Inc.2001-11-14
OS-2000 OPTICAL SONOGRAPHY SYSTEM (K001510)Advanced Diagnostics, Inc.2000-11-30

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Every clearance here is in the API, with alerts when new ones post.