Cleared Traditional

HipCheck

K230045 · Stryker Corp. · Radiology
Sep 2023
Decision
266d
Days
Class 2
Risk

About This 510(k) Submission

K230045 is an FDA 510(k) clearance for the HipCheck, a Automated Radiological Image Processing Software (Class II — Special Controls, product code QIH), submitted by Stryker Corp. (San Jose, US). The FDA issued a Cleared decision on September 29, 2023, 266 days after receiving the submission on January 6, 2023. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number K230045 FDA.gov
FDA Decision Cleared SESE
Date Received January 06, 2023
Decision Date September 29, 2023
Days to Decision 266 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.