23 results
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31ms
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Sources: EU EUDAMED, US FDA
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Status: Ongoing
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FDR Visionary Suite; Model Number: CH-200; Version: (1) 566-16130-23, (2) 566-16130-31, (3)
FDA Enforcement
Class II
·Ongoing·FUJIFILM Healthcare Americas Corporation·February 11, 2026
FDR Visionary Suite, CH-200 Model/Version Numbers: (1) 566-16130-23, (2) 566-16130-31, (3) 566-16130-33
FDA Enforcement
Class II
·Ongoing·FUJIFILM Healthcare Americas Corporation·October 15, 2025
ASPRIRE Cristalle Mammography System (cleared under K212873) installed with the ASPIRE Cristalle Digital Breast Tomosynthesis (DBT) Option (approved under P160031).
FDA Enforcement
Class II
·Ongoing·FUJIFILM Healthcare Americas Corporation·August 6, 2025
The device is a mobile x-ray system designed to work with Fujifilm's GOS and CsI scintillator FDR D-EVO2 (DR-ID) 12XXSE) family of digital x-ray detectors coupled.
FDA Enforcement
Class II
·Ongoing·FUJIFILM Healthcare Americas Corporation·October 2, 2024
FDR Visionary Suite - Intended to generate digital or conventional radiographic images of the skull, spinal column, chest, abdomen, extremities, and other body parts of human anatomies in all routine radiography examinations. Model/Catalog Number: 566-16130-23 566-16130-33
FDA Enforcement
Class II
·Ongoing·FUJIFILM Healthcare Americas Corporation·June 5, 2024
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
Surpria: Software Version V3.11, V3.22
FDA Enforcement
Class II
·Ongoing·FUJIFILM Healthcare Americas Corporation·September 21, 2022
Surpria 64: Software Version V3.11, V3.22
FDA Enforcement
Class II
·Ongoing·FUJIFILM Healthcare Americas Corporation·September 21, 2022
SCENARIA View: Software Version V1.08, V1.09B, V1.09C, V1.09D, V1.0B, V1.0C
FDA Enforcement
Class II
·Ongoing·FUJIFILM Healthcare Americas Corporation·September 21, 2022
Arietta 750 Ultrasound Software Version: V1.0.0 through V2.1.3
FDA Enforcement
Class II
·Ongoing·FujiFilm Healthcare Americas Corporation·November 10, 2021
Arietta 850 Ultrasound- Software Version: V1.0.0 through V4.1.3
FDA Enforcement
Class II
·Ongoing·FujiFilm Healthcare Americas Corporation·November 10, 2021
FujiFilm FDR AQRO (Model DR-XD1000)- A digital mobile X-ray system intended for use in general purpose radiography for generating radiographic images of human anatomy, including adult, pediatric, and neonatal exams
FDA Enforcement
Class II
·Ongoing·FUJIFILM Healthcare Americas Corporation·May 3, 2023
Lisendo 880 Ultrasound Software Version: V1.0 through V4.1.3
FDA Enforcement
Class II
·Ongoing·FujiFilm Healthcare Americas Corporation·November 10, 2021
Arietta 65 Ultrasound Software Versions: V1.0 through V4.0.0
FDA Enforcement
Class II
·Ongoing·FujiFilm Healthcare Americas Corporation·November 10, 2021
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