Cleared Traditional

K210438 - Versana Premier

K210438 is the FDA 510(k) clearance for Versana Premier 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 210-day FDA review.

K210438 · GE Medical Systems Ultrasound and Primary Care Diagnostics · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2021
Decision
210d
Days
Class 2
Risk

K210438 is an FDA 510(k) clearance for the Versana Premier. 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 (Wauwatosa, US). The FDA issued a Cleared decision on September 10, 2021 after a review of 210 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all GE Medical Systems Ultrasound and Primary Care Diagnostics devices

Submission Details

510(k) Number K210438 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 12, 2021
Decision Date September 10, 2021
Days to Decision 210 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
103d slower than avg
Panel avg: 107d · This submission: 210d
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 789
Devices cleared under the same product code (IYN) and FDA review panel - the closest regulatory comparables to K210438.
LELTEK Ultrasound Imaging System (Model: LU700 Series)
K210432 · Leltek, Inc. · Nov 2021
Philips EPIQ Diagnostic Ultrasound System, Philips Affiniti Diagnostic Ultrasound System
K212704 · Philips Medical Systems · Sep 2021
6430 MyLabX75, 6430 MyLab XPro75
K212021 · Esaote, S.P.A. · Sep 2021
LOGIQ E10
K211488 · Ge Healthcare · Sep 2021
HERA W9, HERA W10 Diagnostic Ultrasound System
K211824 · Samsung Medison Co., Ltd. · Sep 2021
EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound System
K211597 · Philips Medical Systems · Sep 2021