Cleared Traditional

Saige-Density

K222275 · DeepHealth, Inc. · Radiology
Dec 2022
Decision
140d
Days
Class 2
Risk

About This 510(k) Submission

K222275 is an FDA 510(k) clearance for the Saige-Density, a Automated Radiological Image Processing Software (Class II — Special Controls, product code QIH), submitted by DeepHealth, Inc. (Cambridge, US). The FDA issued a Cleared decision on December 16, 2022, 140 days after receiving the submission on July 29, 2022. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number K222275 FDA.gov
FDA Decision Cleared SESE
Date Received July 29, 2022
Decision Date December 16, 2022
Days to Decision 140 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.