Cleared Traditional

K260086 - CadAI-B Dx

K260086 is an FDA 510(k) clearance for CadAI-B Dx, manufactured by BeamWorks, Inc.. The device is a Class 2 Radiology device with product code QDQ cleared through the Traditional 510(k) pathway after a 212-day FDA review.

K260086 · BeamWorks, Inc. · Radiology device
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Optimized for regulatory review, auditing and printing
Aug 2026
Decision
212d
Days
Class 2
Risk

K260086 is an FDA 510(k) clearance for the CadAI-B Dx. Classified as Radiological Computer Assisted Detection/diagnosis Software For Lesions Suspicious For Cancer (product code QDQ), Class II - Special Controls.

Submitted by BeamWorks, Inc. (Daegu, KR). The FDA issued a Cleared decision on August 12, 2026 after a review of 212 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.2090 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all BeamWorks, Inc. devices

FDA 510(k) Submission Details - K260086

510(k) Number K260086 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 12, 2026
Decision Date August 12, 2026
Days to Decision 212 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
105d slower than avg
Panel avg: 107d · This submission: 212d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

QDQ Device Classification - Class 2, Special Controls

Product Code QDQ Radiological Computer Assisted Detection/diagnosis Software For Lesions Suspicious For Cancer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.2090
Definition A Radiological Computer Assisted Detection And Diagnostic Software For Suspected Lesions Is An Image Processing Device Intended To Aid In The Detection, Localization, And Characterization Of Lesions Suspicious For Cancer On Acquired Medical Images (e.g., Mammography , Mr, Ct, Ultrasound, Radiography). The Device Detects, Identifies And Characterizes Lesions Suspicious For Cancer Based On Features Or Information Extracted From The Images, And May Provide Information About The Presence, Location, And Characteristics Of The Lesion To The User. Primary Diagnostic And Patient Management Decisions Are Made By The Clinical User.
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 - QDQ Radiological Computer Assisted Detection/diagnosis Software For Lesions Suspicious For Cancer

All 38
Devices cleared under the same product code (QDQ) and FDA review panel - the closest regulatory comparables to K260086.
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