CadAI-B Dx
FDA 510(k) K260086 · BeamWorks, Inc.
Submission
- Device name
- CadAI-B Dx
- Applicant
- BeamWorks, Inc.
Daegu, KR - Received
- January 12, 2026
- Decision date
- August 12, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- QDQ – Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 892.2090
- Specialty
- Radiology
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…
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| K260714 | MammoScreen® (5)QDQ · Special | Therapixel | 06/26/2026SE |
| K253825 | Saige-DxQDQ · Traditional | DeepHealth, Inc. | 06/15/2026SE |
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| K260320 | Lunit INSIGHT MMG (v1.1.10)QDQ · Special | Lunit, Inc. | 04/23/2026SE |
| K253796 | Lunit INSIGHT DBT (V1.2)QDQ · Traditional | Lunit, Inc. | 03/26/2026SE |
| K251474 | Median LCS (internal name) / eyonis LCS (trade name) (1.0)QDQ · Traditional | Median Technologies | 02/06/2026SE |
| K251873 | Saige-DxQDQ · Special | DeepHealth, Inc. | 08/11/2025SE |
| K243341 | Genius AI Detection 2.0QDQ · Traditional | Hologic, Inc. | 07/31/2025SE |
Questions and answers
When was CadAI-B Dx cleared by the FDA?
CadAI-B Dx (K260086) received a 510(k) decision of Substantially Equivalent on August 12, 2026, 212 days after the submission was received.
What is the product code of K260086?
The FDA product code is QDQ – Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer, a Class II (moderate risk) device regulated under 21 CFR 892.2090.