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Fujifilm Medical Systems Synapse 3D gets FDA clearance


K203103 - 510(k) Premarket Notification - FDA

Synapse 3D, Synapse 3D Base Tools v6.1 · Fujifilm Corporation. 26-30, Nishiazabu 2-Chome Minato-Ku. Tokyo, JP 106-8620 · Randy Vader · Fujifilm Medical Systems ...

FUJIFILM Receives FDA Clearance for Synapse(R) 3D - BioSpace

Now FDA 510(k) cleared for sale in the U.S., Synapse 3D is a comprehensive suite of clinical applications that is integrated directly into both Synapse® PACS ...

Fujifilm Receives FDA Clearance for Synapse® 3D - PR Newswire

Because it is vendor-neutral and multi-modality capable, Synapse 3D can be used with virtually any advanced imaging system, such as PET, CT, MR ...

Fujifilm receives FDA clearance for Synapse 3D - Health Imaging

Fujifilm Medical Systems Synapse 3D, which integrates directly into both Synapse PACS and Synapse Cardiovascular, without the need for separate workstations ...

Fujifilm Medical Systems Synapse 3D gets FDA clearance

Fujifilm Medical Systems Synapse 3D gets FDA clearance ... Synapse 3D is a suite of clinical applications that is integrated directly into both ...

5. 510(k) Summary - accessdata.fda.gov

* Synapse 3D Basic Tools (K1 01662), FUJI FILM Medical Systems, U.S.A., Inc. Description of the Device. The SYNAPSE 3D Base Tools software is ...

FDA Grants 510(k) Clearance for Fujifilm's New Endosurgical Image ...

FUJIFILM Medical Systems U.S.A., Inc. is a leading provider of unrivaled diagnostic imaging products and medical informatics solutions that meet ...

FUJIFILM Announces FDA 510(k) Clearance For Latest Innovation ...

17, 2016 /PRNewswire/ -- FUJIFILM Medical Systems U.S.A., Inc., a leading provider of diagnostic imaging products and medical informatics ...

Fujifilm Showcases Enhanced Cloud-based Synapse® Enterprise ...

Synapse® 7xis Fujifilm's next-generation cloud-based enterprise imaging platform that unites data and imaging from radiology, mammography, ...

510(k) Premarket Notification - FDA

K221677 · Synapse 3D Base Tools v6.6 · FUJIFILM Corporation. 26-30 Nishiazabu, 2-Chome. Minato-Ku, JP 106-8620 · Randy Vader · FUJIFILM Healthcare ...

Fujifilm Drives Rapid Adoption of Digital Pathology Technology

October 30, 2023 — Fujifilm Healthcare Americas Corporation, a leading provider of diagnostic and enterprise imaging solutions, ...

Synapse Pathology PACS - Fujifilm Healthcare Solutions

Fujifilm's vendor-agnostic Pathology PACS solution Synapse Pathology, streamlines case management through proprietary advances in image digitization.

Artificial Intelligence and Machine Learning (AI/ML) - FDA

GE Healthcare (GE Medical Systems, LLC) ... Circle Cardiovascular Imaging Inc. Radiology, LLZ. 02/09/2021, K203103, Synapse 3D, Synapse 3D Base Tools v6.1 ...

Fujifilm Launches New MRI System, ECHELON Synergy with Deep ...

Lexington, Mass., August 23, 2023 – FUJIFILM Healthcare Americas Corporation, a leading provider of diagnostic imaging and medical informatics solutions, ...

Fuji enhances PACS with 3D, readies handheld access

Synapse 3D is also directly integrated into the company's cardiovascular imaging system, Synapse Cardiovascular, although this is not yet FDA- ...

K203103.pdf - accessdata.fda.gov

Synapse 3D Base Tools (K120361). FUJIFILM Medical Systems U.S.A., Inc. ... Synapse 3D Base Tools also can be integrated with Fujifilm's Synapse.

Synapse 3D Provides Advanced Visualization and Analysis for MRI ...

March 26, 2013 — FujiFilm Medical Systems U.S.A. Inc. showcased its Synapse 3D at the American College of Cardiology (ACC) conference March ...

Brainlab and Fujifilm Integrate Cutting-Edge Technology, Offering ...

This combined solution is expected to be FDA cleared and available in the United States in mid-2024*. The combination of these technologies ...

Synapse 3D Liver and Kidney Analysis - accessdata.fda.gov

FUJIFILM Medical Systems U.S.A., Inc. December 1, 2014. Ə 0U -\K-Shyan Lin ... Synapse 3D Liver and Kidney Analysis is medical imaging software used with ...

Synapse Partners on LinkedIn: Synaptive Medical Receives FDA ...

Exciting news from Synaptive Medical Inc. as their Near-Infrared fluorescence visualization module, Modus IR, receives #FDA 510(k) clearance, ...