Cleared Traditional

K223347 - UltraSight AI Guidance (FDA 510(k) Clearance)

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

K223347 · Ultrasight, Inc. · Radiology device
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Jul 2023
Decision
265d
Days
Class 2
Risk

K223347 is an FDA 510(k) clearance for the UltraSight AI Guidance. Classified as Image Acquisition And/or Optimization Guided By Artificial Intelligence (product code QJU), Class II - Special Controls.

Submitted by Ultrasight, Inc. (Rehovot, IL). The FDA issued a Cleared decision on July 24, 2023 after a review of 265 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.2100 - 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 Ultrasight, Inc. devices

Submission Details

510(k) Number K223347 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 01, 2022
Decision Date July 24, 2023
Days to Decision 265 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
158d slower than avg
Panel avg: 107d · This submission: 265d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code QJU Image Acquisition And/or Optimization Guided By Artificial Intelligence
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.2100
Definition A Radiological Acquisition And/or Optimization Guidance System Is A Device That Is Intended To Aid In The Acquisition And/or Optimization Of Images And/or Diagnostic Signals. The Device Interfaces With The Acquisition System, Analyzes Its Output, And Provides Guidance And/or Feedback To The Operator For Improving Image And/or Signal Quality.
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

Hogan Lovells US LLP
Janice M. Hogan

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.