Search Results
Found 2 results
510(k) Data Aggregation
K Number
K160942Device Name
Sonablate
Manufacturer
SonaCare Medical, LLC
Date Cleared
2016-12-21
(260 days)
Product Code
PLP
Regulation Number
876.4340Why did this record match?
Applicant Name (Manufacturer) :
SonaCare Medical, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Sonablate® is indicated for transrectal high intensity focused ultrasound (HIFU) ablation of prostatic tissue.
Device Description
Not Found
Ask a Question
K Number
DEN150011Device Name
Sonablate 450
Manufacturer
SonaCare Medical, LLC.
Date Cleared
2015-10-09
(200 days)
Product Code
PLP
Regulation Number
876.4340Why did this record match?
Applicant Name (Manufacturer) :
SonaCare Medical, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Sonablate® 450 is indicated for transrectal high intensity focused ultrasound (HIFU) ablation of prostatic tissue.
Device Description
The Sonablate® 450 is a computer-controlled device designed for transrectal delivery of high intensity focused ultrasound (HIFU) energy to the prostate to ablate regions of unwanted prostatic tissue via thermal ablation. The device makes use of integrated biplanar ultrasound imaging for real-time monitoring, planning, and pre- and post-ablation imaging of the prostate. The system consists of the following main components: Sonasource Console, Sonablate Probe 30/40, Sonachill, Sonablate Multi-Axis Stepper and Probe Arm, and Single Use Components (Probe Tip Kit and Water Path Kit).
Ask a Question
Page 1 of 1