FDA 510(k)

DeepBT Detector-Plus

K-Number: K252190 · 2026-04-10

ApplicantAitewan Biomedical Technology, Inc.

Decision Date2026-04-10

Product CodeQKB

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

DeepBT Detector-Plus is the device name listed in this FDA 510(k) record. The listed applicant is Aitewan Biomedical Technology, Inc.. It received FDA 510(k) clearance on 2026-04-10 under 510(k) number K252190. The device is classified under product code QKB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DeepBT Detector-Plus?

DeepBT Detector-Plus is a medical device that received FDA 510(k) clearance on 2026-04-10. The listed applicant is Aitewan Biomedical Technology, Inc.. The 510(k) number is K252190.

When did DeepBT Detector-Plus receive FDA 510(k) clearance?

DeepBT Detector-Plus received FDA 510(k) clearance on 2026-04-10, under 510(k) number K252190.

Who is the listed applicant for DeepBT Detector-Plus?

The FDA 510(k) record lists Aitewan Biomedical Technology, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DeepBT Detector-Plus?

The FDA product code for DeepBT Detector-Plus is QKB.

Related Devices (Code: QKB)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K262452AutoContour (RADAC V6)Radformation, Inc.K261306AI Contouring (VA10A)Varian Medical Systems K260528OncoStudioOncosoft. Inc.,K252548AI-Rad Companion Organs RTSiemens Healthcare GmbH K253270Contour ProtégéAI+Mim Software, Inc.K260509AutoContour (RADAC V5)Radformation, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.