Cleared Traditional

Vivid iq (K221148) - FDA 510(k) Clearance

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K221148 · GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC · Radiology device
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Jul 2022
Decision
89d
Days
Class 2
Risk

K221148 is an FDA 510(k) clearance for the Vivid iq. 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 & Primary Care Diagnostics, LLC (Wauwatosa, US). The FDA issued a Cleared decision on July 18, 2022 after a review of 89 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 & Primary Care Diagnostics, LLC devices

Submission Details

510(k) Number K221148 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 20, 2022
Decision Date July 18, 2022
Days to Decision 89 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
18d faster than avg
Panel avg: 107d · This submission: 89d
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 631
Devices cleared under the same product code (IYN) and FDA review panel - the closest regulatory comparables to K221148.
ACUSON Juniper Diagnostic Ultrasound System and ACUSON Juniper Select Diagnostic Ultrasound System
K221190 · Siemens Medical Solutions USA, Inc. · Aug 2022
Vivid E80, Vivid E90, Vivid E95
K220882 · Ge Medical Systems Ultrasound And · Jul 2022
Vivid T8, Vivid T9
K221147 · GE Medical Systems Ultrasound and Primary Care Diagnostics · Jul 2022
Vivid S60N, Vivid S70N
K220619 · GE Medical Systems Ultrasound and Primary Care Diagnostics · Jul 2022
Transcranial Doppler Ultrasound System
K213009 · Shenzhen Delica Medical Equipment Co., Ltd. · Jul 2022
V8 Diagnostic Ultrasound System, V7 Diagnostic Ultrasound System
K220975 · Samsung Medison Co., Ltd. · Jun 2022