Medical Device Manufacturer · US , Dallas , TX

Insightec Txsonics, Inc. - FDA 510(k) Cleared Devices

2 submissions · 2 cleared · Since 2006

Recent clearances: 1.5T MRGFUS PELVIC COIL, MRGFUS GENERAL PURPOSE AND BREAST COIL

View 2 510(k) Devices ↓

2

Total

2

Cleared

0

Denied

FDA 510(k) Regulatory Record - Insightec Txsonics, Inc. Radiology ✕

2 devices

1-2 of 2

Cleared Sep 05, 2007

1.5T MRGFUS PELVIC COIL

Radiology · 51d

Cleared Jul 28, 2006

MRGFUS GENERAL PURPOSE AND BREAST COIL

Radiology · 39d

Data Source

Sourced from the FDA 510(k) public files . 176,325 total devices indexed.

Last updated: Sep 28, 2026