K252190
- 510(k) number
- K252190
- Device name
- DeepBT Detector-Plus
- Applicant
- Aitewan Biomedical Technology, Inc. TW
- Product code
- QKB — Radiological Image Processing Software For Radiation
- Decision date
- 2026-04-10
- Date received
- 2025-07-14
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 2.7 MB · U.S. public domain
Also available from FDA: K252190.pdf
Official FDA record: K252190
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.