Cleared Traditional

EFAI Bonesuite XR Bone Age Pro Assessment System (BAP-XR-100)

K234042 · Ever Fortune.Ai, Co., Ltd. · Radiology
Jun 2024
Decision
169d
Days
Class 2
Risk

About This 510(k) Submission

K234042 is an FDA 510(k) clearance for the EFAI Bonesuite XR Bone Age Pro Assessment System (BAP-XR-100), a Automated Radiological Image Processing Software (Class II — Special Controls, product code QIH), submitted by Ever Fortune.Ai, Co., Ltd. (Taichung City, TW). The FDA issued a Cleared decision on June 7, 2024, 169 days after receiving the submission on December 21, 2023. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number K234042 FDA.gov
FDA Decision Cleared SESE
Date Received December 21, 2023
Decision Date June 07, 2024
Days to Decision 169 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code QIH — Automated Radiological Image Processing Software
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.2050
Definition To Provide Automated Radiological Image Processing And Analysis Tools. Software Implementing Artificial Intelligence Including Nonadaptive Machine Learning Algorithms Trained With Clinical And/or Artificial Data. In These Devices, The Algorithm Training Data Typically Impacts Device Performance. Adaptive Ai Algorithms Are Not Within Scope Of This Product Code.