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U.S. Department of Health and Human Services

Product Classification
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Device ultrasound imaging for vascular access for hemodialysis
Regulation Description Ultrasonic pulsed echo imaging system.
Definition Ultrasound imaging for vascular access for hemodialysis
Physical State The device has ultrasound transducers and a computer that runs the imaging software.
Technical Method The device uses ultrasound transducers and an imaging algorithm to provide guidance for the users locating vascular access before the users confirm the position of the vascular access per standard of care and before needle insertion.
Target Area The patient's skin near the site of the vascular access for hemodialysis
Regulation Medical Specialty Radiology
Review Panel Gastroenterology/Urology
Product CodeSGH
Premarket Review Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices (OHT3)
Renal, Gastrointestinal, Obesity and Transplant Devices (DHT3A)
Submission Type 510(k)
Regulation Number 892.1560
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting		 Ineligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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