Cleared Traditional

K203249 - Nucleus.io

K203249 is the FDA 510(k) clearance for Nucleus.io by Nucleushealth, LLC. It is a Class 2 Radiology device (product code LLZ) cleared through the Traditional 510(k) pathway after a 30-day FDA review.

K203249 · Nucleushealth, LLC · Radiology device
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Dec 2020
Decision
30d
Days
Class 2
Risk

K203249 is an FDA 510(k) clearance for the Nucleus.io. 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 Nucleushealth, LLC (San Diego, US). The FDA issued a Cleared decision on December 4, 2020 after a review of 30 days - a notably fast clearance cycle.

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 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 Nucleushealth, LLC devices

Submission Details

510(k) Number K203249 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 04, 2020
Decision Date December 04, 2020
Days to Decision 30 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
77d faster than avg
Panel avg: 107d · This submission: 30d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 Consultant

Regulatory Technology Services, LLC
Prithul Bom

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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