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 TypeAcoustic
Radition SafetyProduct
Annual ReportsNo

Products Classified as PLP

2107High Intensity Ultrasound System For Prostate Tissue AblationHigh Intensity Ultrasound System For Prostate Tissue Ablation.

Total Product Life Cycle (TPLC) Devices

2107High Intensity Ultrasound System For Prostate Tissue AblationHigh Intensity Ultrasound System For Prostate Tissue Ablation.

Pre-market Notifications for PLP

K211858TULSA-PRO SystemProfound Medical Inc.
K202286Tulsa-Pro SystemProfound Medical Inc
K191200TULSA-PRO SystemPROFOUND MEDICAL INC.
K172721FOCAL ONEEDAP Technomed, Inc.
K172285Ablatherm FusionEDAP TECHNOMED, INC.
K160942SonablateSonaCare Medical, LLC
K153023Ablatherm Integrated ImagingEDAP TECHNOMED, INC.

Global Unique Device Identification Database

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

Maude Adverse Events

SONABLATEFOCUS SURGERY, INC.2019-09-26
SONABLATEFOCUS SURGERY, INC2019-05-02
SONABLATE 500SONACARE MEDICAL2017-04-11
EDAP ABLATHERM INTEGRATED IMAGINGEDAP TMS FRANCE SA2017-02-17
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