Radiation Emitting Electronic Product Codes

• Product: lithotriptor, extracorporeal shock-wave, urological
• Regulation Description: Extracorporeal shock wave lithotripter.
• Product Description: Gastroenterology/Urology Ultrasonic Medical Devices (Miscellaneous)
• Product Code: LNS
• Radiation Type: Acoustic
• Radiation Safety Report Type Required?: None
• Annual Reports Required?: No
• Regulation Number: 876.5990
• Applicable Performance Standard(s): No standard applicable. General Radiological Health requirements apply. [1000-1005]

Guidance Documents

• Guidance for the Content of Premarket Notifications (510(k)s) for Extracorporeal Shock Wave Lithotripters Indicated for the Fragmentation of Kidney and Ureteral Calculi

• Checklist for Mechanical Lithotripters and Stone Dislodgers used in Gastroenterology and Urology