Ablatherm Integrated Imaging— 510(k) K153023

Name: FDA 510(k) clearance K153023
Creator: U.S. Food and Drug Administration
Published: 2015-11-06

Substantially Equivalent

Edap Technomed, Inc.

FDA 510(k) clearance K153023 for Ablatherm Integrated Imaging, Substantially Equivalent on 2015-11-06. Applicant: Edap Technomed, Inc.. Device class: 2.

Clearance details

Applicant: Edap Technomed, Inc.
Product code: Code PLP
Device class: Class 2
Regulation: 21 CFR 876.4340
Advisory panel: Gastroenterology, Urology
Date received: 2015-10-15
Decision date: 2015-11-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Austin, TX, US

Download summary PDF View on FDA.gov ↗

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Recalls naming K153023

K-number listed on FDA's recall record

Z-0049-2018 — Ablatherm(R) Integrated Imaging, High Intensity Ultrasound System For Prostate Tissue Ablation Transrectal high intensity focused ultrasound (HIFU) ablation of prostate tissueClass II·Terminated·Edap Technomed Inc.·20170814

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K153023.

Data sourced from openFDA. This site is unofficial and independent of the FDA.