Atlas FDA

SGH

1 FDA 510(k) clearances · Product code

FDA profile

Official device name
Ultrasound Imaging For Vascular Access For Hemodialysis
Device class
Class II (moderate risk)
Regulation
21 CFR 892.1560
Medical specialty
Radiology
FDA definition
Ultrasound imaging for vascular access for hemodialysis
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RecordFirmDate
X9 Ultrasound System (K251673)X9, Inc.2025-10-17

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