Automated Radiological Image Processing Software
Radiology · 21 CFR 892.2050
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.
Recent MDR events
10 adverse event reports on file
- SYNAPSE PACSJul 2, 2026MalfunctionFujifilm Healthcare Americas Corporation3004972322-2026-00002
- ORIGIN DATA MANAGEMENT (VERSION 3.2, SOFTWARE COMPONENT)Apr 9, 2026MalfunctionBrainlab Se8043933-2026-00021
- ORIGIN DATA MANAGEMENT (VERSION 3.2, SOFTWARE COMPONENT)Feb 26, 2026MalfunctionBrainlab Se8043933-2026-00011
- ORIGIN DATA MANAGEMENT (VERSION 3.2, SOFTWARE COMPONENT)Aug 13, 2025MalfunctionBrainlab Ag8043933-2025-00058
- SONIO DETECTJun 25, 2025MalfunctionSonioMW5171987
- BRAIN LAB IMAGING SYSTEMJun 2, 2025MalfunctionBrainlab AgMW5171002
- ORIGIN DATA MANAGEMENT (VERSION 3.2, SOFTWARE COMPONENT)May 2, 2025MalfunctionBrainlab Ag8043933-2025-00033
- ORIGIN DATA MANAGEMENT (SOFTWARE COMPONENT)Jan 17, 2025MalfunctionBrainlab Ag8043933-2025-00005
- ORIGIN DATA MANAGEMENT (SOFTWARE COMPONENT)Dec 23, 2024MalfunctionBrainlab Ag8043933-2024-00090
- BRAINLAB ELEMENTS 6.0;ELEMENTS IMAGE FUSION;ELEMENTS IMAGE FUSION ANGIO;ELEMEJul 29, 2024InjuryBrainlab AgMW5157801
Event type breakdown
Most-reported manufacturers
Recalls
2 recall events for this product code
- PIE Medical Imaging B.V.Open, ClassifiedJul 21, 2026
3mensio Workstation (Vascular Fenestrated) software
User measurement value reported by diagnostic bioimaging software intended to measure/visualize cardiovascular structures may be larger (0.8% to 34.4%) than the actual anatomical dimension, if all the following occur: affected software is used, and the user has access only to 3D Echo OR Mitral 3D Echo, and the dataset being analyzed is a Philips 3D echo dataset containing Color Doppler information
Z-2767-2026 · View FDA record ↗ - Caption HealthTerminatedUnknown
Version: 1.2.0 (1.2.0+85ela410) Caption Health, Caption AI, Ultrasound Imaging System Application Software (GMDN: 40873), UDI: (01)00860003586303(10)1.2.0)
The firm is aware of a issue with ultrasound software that results in unintended video frames being included. This could lead to an incorrect automated ejection fraction (AutoEF) and image quality score (IQS) estimates.
Z-2111-2021 · View FDA record ↗
Registered firms
600 firms currently registered for this product code
Change Healthcare Canada Company
RICHMOND British Columbia, CA
Pearl Inc.
West Hollywood, CA, US
Whiterabbit Ai Inc
Redwood City, CA, US
Spectrum Dynamics Medical Inc.
Sarasota, FL, US
Wipro Ge Medical Device Manufacturing Private Limited
Bangalore Karnataka, IN
Ge Medical Systems Scs
BUC, FR
Intuitive Surgical, Inc.
Santa Clara, CA, US
Bio Analitica Argentina S.a.
Ciudad Autonoma de Buenos Aires, AR
Philips Ultrasound Llc
BOTHELL, WA, US
3d-side
Mont Saint Guibert Brabant Wallon, BE
Samsung Medison Co., Ltd.
Gumi-si Gyeongbuk, KR
Philips India Limited - Ultrasound Business Unit
Bengaluru Karnataka, IN
Viz.ai, Inc.
Cary, NC, US
Disior Oy
Helsinki Uusimaa, FI
Philips Global Business Services Llp - Ultrasound Business Unit
Baner Pune Maharashtra, IN
Koios Medical, Inc.
New York, NY, US
Ge Medical Systems Ultrasound And Primary Care Diagnostics, Llc
Waukesha, WI, US
Philips Ultrasound Llc
Reedsville, PA, US
Siemens Medical Solutions Usa, Inc.
Hoffman Estates, IL, US
Expeditors
Mississauga Ontario, CA
Viz.ai Israel Ltd
Tel Aviv, IL
Siemens Healthineers Ag
ERLANGEN Bavaria, DE
Orthogrid Systems, Inc
Midvale, UT, US
Ge Healthcare Austria Gmbh & Co Og
ZIPF Oberosterreich, AT
510(k) clearances
319 clearances for this product code
- Mediaire GmbHAug 7, 2026
K252571 · mdprostate
- 3DIEMME SRLAug 4, 2026
K253902 · RealGUIDE
- Hermes Medical Solutions ABJul 31, 2026
K253835 · Affinity
- Curemetrix, Inc.Jul 30, 2026
K260980 · cmAngio® V2.0
- Cleerly, Inc.Jul 29, 2026
K261210 · Cleerly Plaque
- ROPCA ApSJul 24, 2026
K260192 · DIANA
- Airs Medical, Inc.Jul 24, 2026
K261349 · SwiftMR
- Velmeni, Inc.Jul 23, 2026
K254096 · VELMENI for DENTISTS (V4D) 3D