Atlas FDA

JAB

2 FDA 510(k) clearances · Product code

FDA profile

Official device name
System, X-Ray, Fluoroscopic, Non-Image-Intensified
Device class
Class II (moderate risk)
Regulation
21 CFR 892.1660
Medical specialty
Radiology
Flags
Third-party review eligible
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RecordFirmDate
IMAGING JET SYSTEM (K970782)General Robotic Devices, Inc.1997-11-13
ZIKON 100 DIGITAL X-RAY SYSTEM (K813032)Kontron Instruments, Inc.1981-11-24

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