Cleared Traditional

K251322 - Venue

Also marketed or referenced as:
Venue Go Venue Fit Venue Sprint

K251322 is the FDA 510(k) clearance for Venue by GE Medical Systems Ultrasound and Primary Care Diagnostics. It is a Class 2 Radiology device (product code IYN) cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K251322 · GE Medical Systems Ultrasound and Primary Care Diagnostics · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2025
Decision
87d
Days
Class 2
Risk

K251322 is an FDA 510(k) clearance for the Venue. Classified as System, Imaging, Pulsed Doppler, Ultrasonic within the IYN classification (a category covering pulsed Doppler and ultrasound imaging systems), Class II - Special Controls.

Submitted by GE Medical Systems Ultrasound and Primary Care Diagnostics (Waukesha, US). The FDA issued a Cleared decision on July 25, 2025 after a review of 87 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1550 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all GE Medical Systems Ultrasound and Primary Care Diagnostics devices

Submission Details

510(k) Number K251322 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 29, 2025
Decision Date July 25, 2025
Days to Decision 87 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
20d faster than avg
Panel avg: 107d · This submission: 87d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code IYN System, Imaging, Pulsed Doppler, Ultrasonic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1550
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Peers - IYN System, Imaging, Pulsed Doppler, Ultrasonic

All 779
Devices cleared under the same product code (IYN) and FDA review panel - the closest regulatory comparables to K251322.
Sonosite LX and Sonosite PX Ultrasound Systems
K251106 · FUJIFILM Sonosite, Inc. · Aug 2025
Diagnostic Ultrasound System (MX7)
K251192 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Aug 2025
ACUSON Sequoia Diagnostic Ultrasound System
K251481 · Siemens Medical Solutions USA, Inc. · Aug 2025
EPIQ Series Diagnostic Ultrasound System
K251455 · Philips Ultrasound, LLC · Jul 2025
V8 Diagnostic Ultrasound System
K250999 · Samsung Medison Co., Ltd. · Jul 2025
Vivid Pioneer
K251169 · GE Medical Systems Ultrasound and Primary Care Diagnostics · Jul 2025