K252190

The DeepBT Detector-Plus is image-processing software cleared under product code QKB — FDA's catch-all category for radiological image processing software, which over the last five years has come to be dominated by AI/ML-assisted detection and triage tools. The record doesn't specify imaging modality; QKB covers CT, MRI, and X-ray applications indiscriminately.

Reviewed by the Radiology panel via the Traditional 510(k) pathway. The roughly nine-month review clock from July 2025 filing to April 2026 clearance is at the longer end of FDA's 90-day target, consistent with recent QKB submissions as the agency works through the volume of AI imaging filings.

Aitewan Biomedical is Taipei-based. Foreign-applicant AI imaging submissions are an increasing share of QKB traffic; earlier waves tended to route through US subsidiaries, while direct applications from Asian developers are now common.