Cleared Traditional

Elucis (K220649) - FDA 510(k) Clearance

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

K220649 · Realize Medical, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2023
Decision
316d
Days
Class 2
Risk

K220649 is an FDA 510(k) clearance for the Elucis. Classified as System, Image Processing, Radiological within the LLZ classification (a category encompassing advanced image processing and PACS-adjacent software), Class II - Special Controls.

Submitted by Realize Medical, Inc. (Ottawa, CA). The FDA issued a Cleared decision on January 17, 2023 after a review of 316 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.2050 - 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: Incremental AI imaging tool. Moderate-to-high equivalence dependency. Overall, this clearance reflects a predicate-aligned approval typical of modern AI radiology extensions - not a novel clinical breakthrough, but a validated iteration within an established regulatory category.

View all Realize Medical, Inc. devices

Submission Details

510(k) Number K220649 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 07, 2022
Decision Date January 17, 2023
Days to Decision 316 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
209d slower than avg
Panel avg: 107d · This submission: 316d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LLZ System, Image Processing, Radiological
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.2050
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 - LLZ System, Image Processing, Radiological

All 818
Devices cleared under the same product code (LLZ) and FDA review panel - the closest regulatory comparables to K220649.
Advanced MyHip Planner
K221725 · Medacta International S.A. · Jan 2023
PerfusionGo Plus
K221627 · Yukun (Beijing) Technology Co., Ltd. · Jan 2023
TruPlan Computed Tomography (CT) Imaging Software
K222593 · Circle Cardiovascular Imaging, Inc. · Jan 2023
MIM – Additional Tracers
K223800 · Mim Software, Inc. · Jan 2023
MR Diffusion Perfusion Mismatch V1.0
K223502 · Olea Medical · Jan 2023
AIBOLIT 3D+
K222458 · Aibolit Technologies, LLC · Jan 2023