High Intensity Ultrasound System For Prostate Tissue Ablation

Product Code: PLP

Gastroenterology/Urology Ultrasonic Medical Devices (Miscellaneous)

Definition: Prostate Tissue Ablation.

Applicable Standards: No Standard Applicable. General Radiological Health Requirements Apply. [1000-1005]

Code of Federal Regulations: 876.4340

• Radiation Type: Acoustic
• Radition Safety: Product
• Annual Reports: No

Products Classified as PLP

2107

High Intensity Ultrasound System For Prostate Tissue Ablation

High Intensity Ultrasound System For Prostate Tissue Ablation.

Total Product Life Cycle (TPLC) Devices

2107

High Intensity Ultrasound System For Prostate Tissue Ablation

High Intensity Ultrasound System For Prostate Tissue Ablation.

Pre-market Notifications for PLP

K211858	TULSA-PRO System	Profound Medical Inc.
K202286	Tulsa-Pro System	Profound Medical Inc
K191200	TULSA-PRO System	PROFOUND MEDICAL INC.
K172721	FOCAL ONE	EDAP Technomed, Inc.
K172285	Ablatherm Fusion	EDAP TECHNOMED, INC.
K160942	Sonablate	SonaCare Medical, LLC
K153023	Ablatherm Integrated Imaging	EDAP TECHNOMED, INC.

Global Unique Device Identification Database

• 00868108000274: High Intensity Ultrasound System For Prostate Tissue Ablation
• 00868108000267: High Intensity Ultrasound System For Prostate Tissue Ablation
• 00868108000229: High Intensity Ultrasound System For Prostate Tissue Ablation
• 00868108000212: High Intensity Ultrasound System For Prostate Tissue Ablation
• 07540281000182: High Intensity Ultrasound System For Prostate Tissue Ablation
• 07540281000175: High Intensity Ultrasound System For Prostate Tissue Ablation
• 07540281000168: High Intensity Ultrasound System For Prostate Tissue Ablation
• 07540281000151: High Intensity Ultrasound System For Prostate Tissue Ablation
• 07540281000113: High Intensity Ultrasound System For Prostate Tissue Ablation
• 07540281000106: High Intensity Ultrasound System For Prostate Tissue Ablation
• 07540281000090: High Intensity Ultrasound System For Prostate Tissue Ablation
• 07540281000083: High Intensity Ultrasound System For Prostate Tissue Ablation
• 07540281000076: High Intensity Ultrasound System For Prostate Tissue Ablation
• 07540281000069: High Intensity Ultrasound System For Prostate Tissue Ablation
• 07540281000052: High Intensity Ultrasound System For Prostate Tissue Ablation

Maude Adverse Events

SONABLATE	FOCUS SURGERY, INC.	2019-09-26
SONABLATE	FOCUS SURGERY, INC	2019-05-02
SONABLATE 500	SONACARE MEDICAL	2017-04-11
EDAP ABLATHERM INTEGRATED IMAGING	EDAP TMS FRANCE SA	2017-02-17