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U.S. Department of Health and Human Services

Product Classification
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Device spatial imaging for display of endoscope position
Regulation Description Endoscope and accessories.
Definition To detect and display the shape of an inserted endoscope.
Physical State A control unit that communicates with an endoscope/accessory probe, a receiver dish, and display monitor.
Technical Method Measures electromagnetic fields from the endoscope or an accessory within an endoscope to determine the shape of an inserted endoscope, and displays it on a monitor.
Target Area Gastrointestinal system
Regulation Medical Specialty Gastroenterology/Urology
Review Panel Gastroenterology/Urology
Product CodePGU
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 876.1500
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting		 Eligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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