DeepBT Detector-Plus— 510(k) K252190
Substantially EquivalentAitewan Biomedical Technology, Inc.
FDA 510(k) clearance K252190 for DeepBT Detector-Plus, Substantially Equivalent on 2026-04-10. Applicant: Aitewan Biomedical Technology, Inc.. Device class: 2.
Summary
DeepBT Detector-Plus is image processing software under QKB, the product code for radiological image processing software used in radiation therapy. The code's definition covers AI-based image processing and analysis tools used in the radiation therapy workflow, and it excludes primary dose calculation and plan optimization. The record doesn't say which task this one performs, and the name alone doesn't settle it.
Class II, 21 CFR 892.2050. The Radiology panel reviewed it as a Traditional 510(k).
Aitewan Biomedical Technology filed from Taipei, Taiwan. Review took 270 days (July 14, 2025 to April 10, 2026).
Clearance details
- Applicant
- Aitewan Biomedical Technology, Inc.
- Product code
- Product code QKB
- Device class
- Class 2
- Regulation
- 21 CFR 892.2050
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Taipei, TW
Recent devices under product code QKB
view allData sourced from openFDA. This site is unofficial and independent of the FDA.