Cleared Traditional

Syngo Carbon Clinicals

K232856 · Siemens Healthcare GmbH · Radiology

Dec 2023

Decision

77d

Days

Class 2

Risk

About This 510(k) Submission

K232856 is an FDA 510(k) clearance for the Syngo Carbon Clinicals, a Automated Radiological Image Processing Software (Class II — Special Controls, product code QIH), submitted by Siemens Healthcare GmbH (Forchheim, DE). The FDA issued a Cleared decision on December 1, 2023, 77 days after receiving the submission on September 15, 2023. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number	K232856 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 15, 2023
Decision Date	December 01, 2023
Days to Decision	77 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.