Cleared Traditional

K260673 - LOGIQ Vita (FDA 510(k) Clearance)

Also includes:

LOGIQ Vita Pro LOGIQ Vita Express LOGIQ Vita Plus LOGIQ Vita Power LOGIQ S20 LOGIQ S20 Pro LOGIQ S20 Express LOGIQ S20 Plus LOGIQ S20 Power

K260673 · GE Medical Systems Ultrasound and Primary Care Diagnostics · Radiology device

Mar 2026

Decision

22d

Days

Class 2

Risk

K260673 is an FDA 510(k) clearance for the LOGIQ Vita. This device is classified as a System, Imaging, Pulsed Doppler, Ultrasonic (Class II - Special Controls, product code IYN).

Submitted by GE Medical Systems Ultrasound and Primary Care Diagnostics (Waukesha, US). The FDA issued a Cleared decision on March 24, 2026, 22 days after receiving the submission on March 2, 2026.

This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1550.

Submission Details

510(k) Number	K260673 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	March 02, 2026
Decision Date	March 24, 2026
Days to Decision	22 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF