Cleared Traditional

aprevo? Digital Segmentation

K231955 · Carlsmed, Inc. · Radiology

Nov 2023

Decision

123d

Days

Class 2

Risk

About This 510(k) Submission

K231955 is an FDA 510(k) clearance for the aprevo? Digital Segmentation, a Automated Radiological Image Processing Software (Class II — Special Controls, product code QIH), submitted by Carlsmed, Inc. (Carlsbad, US). The FDA issued a Cleared decision on November 3, 2023, 123 days after receiving the submission on July 3, 2023. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number	K231955 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 03, 2023
Decision Date	November 03, 2023
Days to Decision	123 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.