Cleared Traditional

K221932 - Omni Legend

K221932 is an FDA 510(k) clearance for Omni Legend, manufactured by Ge Healthcare. The device is a Class 2 Radiology device with product code KPS cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K221932 · Ge Healthcare · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2022
Decision
63d
Days
Class 2
Risk

K221932 is an FDA 510(k) clearance for the Omni Legend. Classified as System, Tomography, Computed, Emission (product code KPS), Class II - Special Controls.

Submitted by Ge Healthcare (Tirat Hacarmel, IL). The FDA issued a Cleared decision on September 2, 2022 after a review of 63 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1200 - 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 Healthcare devices

FDA 510(k) Submission Details - K221932

510(k) Number K221932 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 01, 2022
Decision Date September 02, 2022
Days to Decision 63 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
44d faster than avg
Panel avg: 107d · This submission: 63d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KPS Device Classification - Class 2, Special Controls

Product Code KPS System, Tomography, Computed, Emission
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1200
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 - KPS System, Tomography, Computed, Emission

All 248
Devices cleared under the same product code (KPS) and FDA review panel - the closest regulatory comparables to K221932.
uMI Panorama
K223325 · Shanghai United Imaging Healthcare Co., Ltd. · Mar 2023
Biograph Vision Quadra PET/CT System
K223547 · Siemens Medical Solutions USA, Inc. · Dec 2022
DynamicIQ
K222895 · GE Medical Systems SCS · Nov 2022
EFAI CARDIOSUITE SPECT Myocardial Perfusion Agile Workflows
K213731 · Ever Fortune.Ai, Co., Ltd. · May 2022
Radialis PET Camera
K214062 · Radialis, Inc. · Feb 2022
SubtlePET
K211964 · Subtle Medical, Inc. · Sep 2021