CadAI-B Dx— 510(k) K260086
Substantially EquivalentBeamWorks, Inc.
FDA 510(k) clearance K260086 for CadAI-B Dx, Substantially Equivalent on 2026-08-12. Applicant: BeamWorks, Inc.. Device class: 2.
Summary
BeamWorks' CadAI-B Dx is filed under product code QDQ, radiological computer assisted detection/diagnosis software for lesions suspicious for cancer. The record has no description beyond the name and that code name.
Class II, 21 CFR 892.2090. Radiology is both the classification panel and the review panel, and it came in as a Traditional 510(k).
BeamWorks filed from Daegu, South Korea. The decision came 212 calendar days after receipt (January 12 to August 12, 2026), and it was substantially equivalent.
Clearance details
- Applicant
- BeamWorks, Inc.
- Product code
- Product code QDQ
- Device class
- Class 2
- Regulation
- 21 CFR 892.2090
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Daegu, KR
Recent devices under product code QDQ
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