Cleared Traditional

K253794 - Prostate Core

K253794 is an FDA 510(k) clearance for Prostate Core, manufactured by Lucida Medical, Ltd.. The device is a Class 2 Radiology device with product code QIH cleared through the Traditional 510(k) pathway after a 255-day FDA review.

K253794 · Lucida Medical, Ltd. · Radiology device
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Aug 2026
Decision
255d
Days
Class 2
Risk

K253794 is an FDA 510(k) clearance for the Prostate Core. Classified as Automated Radiological Image Processing Software within the QIH classification (a category dominated by AI-based automated radiology processing systems), Class II - Special Controls.

Submitted by Lucida Medical, Ltd. (Cambridge, GB). The FDA issued a Cleared decision on August 10, 2026 after a review of 255 days - an extended review 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-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 Lucida Medical, Ltd. devices

FDA 510(k) Submission Details - K253794

510(k) Number K253794 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 28, 2025
Decision Date August 10, 2026
Days to Decision 255 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
148d slower than avg
Panel avg: 107d · This submission: 255d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

QIH Device Classification - Class 2, Special Controls

Product Code QIH Automated Radiological Image Processing Software
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.2050
Definition To Provide Automated Radiological Image Processing And Analysis Tools. Software Implementing Artificial Intelligence Including Nonadaptive Machine Learning Algorithms Trained With Clinical And/or Artificial Data. In These Devices, The Algorithm Training Data Typically Impacts Device Performance. Adaptive Ai Algorithms Are Not Within Scope Of This Product Code.
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 - QIH Automated Radiological Image Processing Software

All 320
Devices cleared under the same product code (QIH) and FDA review panel - the closest regulatory comparables to K253794.
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