GE LOGIQ 7 Ultrasound BT05

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K052441 ↗

FDA Product Code

IYN

Device Class

Class II

Regulation

21 CFR Part 892.1550

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

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• What is the GE LOGIQ 7 Ultrasound BT05 used for?

  The GE LOGIQ 7 Ultrasound BT05 is a general-purpose diagnostic ultrasound system designed for digital acquisition, processing, and display of ultrasound images using pulsed echo and Doppler imaging techniques.

• How is the GE LOGIQ 7 Ultrasound BT05 supplied?

  The device is supplied by General Electric Co. and includes a CRT or LCD display, LCD touch panel, and computer keyboard for operation.

• What regulatory clearance does the GE LOGIQ 7 Ultrasound BT05 have?

  The device has received FDA 510(k) clearance with number K052441, classified as a special clearance device reviewed by the Radiology advisory committee, and determined to be substantially equivalent.

• Is the GE LOGIQ 7 Ultrasound BT05 reusable or single-use?

  The device is a diagnostic ultrasound system intended for repeated use in clinical settings, not as a single-use device.