CadAI-B Dx— 510(k) K260086

Substantially Equivalent

BeamWorks, Inc.

FDA 510(k) clearance K260086 for CadAI-B Dx, Substantially Equivalent on 2026-08-12. Applicant: BeamWorks, Inc.. Device class: 2.

Clearance details

Applicant
BeamWorks, Inc.
Product code
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
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