18 results
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7ms
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Sources: EU EUDAMED, US FDA
BD Synapsys Informatics Solution with software versions: 4.20, 4.30, 5.10, 5.20 and 5.30- IVD standalone laboratory software solution providing data management and workflow management functionality across locations where clinical diagnostic activities take place. Catalog Number: 444150
FDA Enforcement
Class II
·Ongoing·Becton Dickinson & Co.·October 16, 2024
BD Synapsys Informatics Solution, Catalog Number 444150
FDA Enforcement
Class II
·Ongoing·Becton Dickinson & Co.·July 12, 2023
BD Synapsys Informatics Solution (Laboratory Solution) Version or Model: 444150 Catalog Number: 444150
FDA Enforcement
Class II
·Ongoing·Becton Dickinson & Co.·December 11, 2024
BD Kiestra Urine Culture Application Powered by BD Synapsys Informatics Solution; Catalog (Ref): 444900;
FDA Enforcement
Class II
·Ongoing·Becton Dickinson & Co.·August 21, 2024
BD Veritor Connect Software, labeled as the following: 1. Veritor (NUC), Catalog Number: 444881. Transfers in vitro diagnostic results data on the BD Veritor Plus Analyzer to BD Synapsys.
FDA Enforcement
Class II
·Ongoing·Becton Dickinson & Co.·October 29, 2025
BD Kiestra InoqulA+ with BD Kiestra" InoqulA+" and BeA Software version 5.1 and 5.1.1 as part of the Icefall A platform. An in vitro diagnostic medical device intended to automate specimen processing according to user-defined procedures and protocols. Catalog (Ref) No. : 447213
FDA Enforcement
Class II
·Ongoing·Becton Dickinson & Co.·April 26, 2023
Synapse PACS Software Version 7.4.x; Software Versions: 7.4.000, 7.4.001, 7.4.010, 7.4.100, 7.4.110, 7.4.200.
FDA Enforcement
Class II
·Ongoing·FUJIFILM Healthcare Americas Corporation·March 26, 2025
Synapse PACS - Radiological Image Processing System - Product Usage: intended for use, as a web based application, on an off-the-shelf PC meeting or exceeding minimum specifications and networked with FUJIFILM Synapse PACS Software (Server).
FDA Enforcement
Class II
·Ongoing·Fujifilm Medical Systems U.S.A., Inc.·April 14, 2021
Fujifilm Synapse PACS Software Version 5.5.x and 5.7.x- intended as interface to the FUJIFILM Synapse PACS Software (Server)
FDA Enforcement
Class II
·Ongoing·Fujifilm Medical Systems U.S.A., Inc.·July 8, 2020
Synapse PACS - Version 7.2.100
FDA Enforcement
Class II
·Ongoing·FUJIFILM Healthcare Americas Corporation·March 13, 2024
Synapse PACS - Version 7.1.000
FDA Enforcement
Class II
·Ongoing·FUJIFILM Healthcare Americas Corporation·March 13, 2024
Synapse PACS - Version 7.2.200
FDA Enforcement
Class II
·Ongoing·FUJIFILM Healthcare Americas Corporation·March 13, 2024
Synapse PACS - Version 7.2.000
FDA Enforcement
Class II
·Ongoing·FUJIFILM Healthcare Americas Corporation·March 13, 2024
Synapse PACS - Version 7.3.000
FDA Enforcement
Class II
·Ongoing·FUJIFILM Healthcare Americas Corporation·March 13, 2024
Synapse PACS - Version 7.1.000US
FDA Enforcement
Class II
·Ongoing·FUJIFILM Healthcare Americas Corporation·March 13, 2024
Synapse PACS Software Versions 5.1 and higher
FDA Enforcement
Class II
·Ongoing·Fujifilm Medical Systems U.S.A., Inc.·January 27, 2021
Synapse CV 6. with AR. A web-based application as the primary user interface for the processing of medical images.
FDA Enforcement
Class II
·Ongoing·FUJIFILM Healthcare Americas Corporation·February 28, 2024
Synapse Cardiology PACS V7.3.0, V7.2, V7.1, V7.0. A web-based application as the primary user interface for the processing of medical images.
FDA Enforcement
Class II
·Ongoing·FUJIFILM Healthcare Americas Corporation·February 28, 2024