1.5T MRGFUS PELVIC COIL— 510(k) K071966

Name: FDA 510(k) clearance K071966
Creator: U.S. Food and Drug Administration
Published: 2007-09-05

Substantially Equivalent

Insightec-Txsonics, Inc.

FDA 510(k) clearance K071966 for 1.5T MRGFUS PELVIC COIL, Substantially Equivalent on 2007-09-05. Applicant: Insightec-Txsonics, Inc.. Device class: 2.

Clearance details

Applicant: Insightec-Txsonics, Inc.
Product code: Code MOS
Device class: Class 2
Regulation: 21 CFR 892.1000
Advisory panel: Radiology
Date received: 2007-07-16
Decision date: 2007-09-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dallas, TX, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code MOS

view all

K262330 — dS Breast 7ch 1.5TdS Breast 7ch 3.0TdS Breast 16ch 1.5TdS Breast 16ch 3.0TdS Breast Coil 7ch 1.5TdS Sentinelle Breast 16ch 1.5TdS Sentinelle Breast 16ch 3.0T2026-07-30
K262294 — dS FootAnkle 16Ch 1.5T +5 more2026-07-24
K260947 — 0.55T 12Ch Breast Coil2026-04-23
K252587 — HD 8Ch Wrist Array2026-04-14
K252876 — GEM Flex Coil 16-L Array, 3.0T Receive Only +2 more2026-04-01

More clearances from Insightec-Txsonics, Inc.

view all

K061715 — MRGFUS GENERAL PURPOSE AND BREAST COIL2006-07-28

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