Data / Medical devices / Japan / FUJIFILM Corporation Medical Systems Research & Development Center Minamiaoyama
FUJIFILM Corporation Medical Systems Research & Development Center Minamiaoyama: FDA-registered device maker in Minato Tokyo, Japan, 14 510(k) clearances
FUJIFILM Corporation Medical Systems Research & Development Center Minamiaoyama is registered with the FDA (registration 3005930550) in Minato Tokyo, Japan. It lists 4 device types. The FDA files 14 510(k) clearances under its listings, the newest dated May 27, 2026. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3005930550
- Address
- 6 Chome 6-15 Minamiaoyama, Minato Tokyo, Japan, 107-0062
- Owner or operator
- FUJIFILM CORPORATION (8031568)
- Roles
- Manufacturer
- First device listed
- August 31, 2012
- Registered through
- 2026
- Brand names listed
- Endoscope Simulator, Kidney Analysis, Liver Analysis, Lung Analysis Resection, Synapse 3D Base Tools (V7.2), Synapse 3D Base Tools V6.6, Synapse 3D Base Tools V7, Synapse 3D Blood Flow Analysis and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Automated Radiological Image Processing Software | QIH | 2 | Manufacturer | accessdata.fda.gov |
| Lung Computed Tomography System, Computer-Aided Detection | OEB | 2 | Manufacturer | accessdata.fda.gov |
| System, Image Processing, Radiological | LLZ | 2 | Manufacturer | accessdata.fda.gov |
| System, X-Ray, Tomography, Computed | JAK | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| May 27, 2026 | K254075 | Synapse Lung Nodule AI | OEB | Substantially Equivalent | Fujifilm Corporation | accessdata.fda.gov |
| April 30, 2026 | K254189 | Synapse 3D Base Tools (V7.2) | QIH | Substantially Equivalent | Fujifilm Corporation | accessdata.fda.gov |
| May 21, 2025 | K243762 | Synapse 3D Base Tools (V7.0) | QIH | Substantially Equivalent | Fujifilm Corporation | accessdata.fda.gov |
| November 10, 2022 | K221677 | Synapse 3D Base Tools v6.6 | LLZ | Substantially Equivalent | Fujifilm Corporation | accessdata.fda.gov |
| August 27, 2020 | K200973 | Synapse 3D Cardiac Tools | LLZ | Substantially Equivalent | Fujifilm Corporaton | accessdata.fda.gov |
| October 18, 2019 | K191544 | Synapse 3D Blood Flow Analysis | LLZ | Substantially Equivalent | Fujifilm Corporation | accessdata.fda.gov |
| September 25, 2018 | K181773 | Synapse 3D Optional Tools | LLZ | Substantially Equivalent | Fujifilm Corporation | accessdata.fda.gov |
| April 6, 2017 | K162287 | Synapse 3D Perfusion Analysis | LLZ | Substantially Equivalent | Fujifilm Medical Systems U.S.A, Inc. | accessdata.fda.gov |
| December 1, 2014 | K142521 | Synapse 3D Liver and Kidney Analysis | LLZ | Substantially Equivalent | Fujifilm Meidcal Systems U.S.A.,Inc. | accessdata.fda.gov |
| September 3, 2014 | K141514 | SYNAPSE 3D TENSOR ANALYSIS | LLZ | Substantially Equivalent | Fujifilm Meidcal Systems U.S.A.,Inc. | accessdata.fda.gov |
| June 14, 2013 | K130542 | SYNAPSE 3D LUNG AND ABDOMEN ANALYSIS | LLZ | Substantially Equivalent | Fujifilm Medical System U.S.A., Inc. | accessdata.fda.gov |
| January 22, 2013 | K123566 | SYNAPSE 3D COLON ANALYSIS | LLZ | Substantially Equivalent | Fujifilm Medical Systems U.S.A, Inc. | accessdata.fda.gov |
| June 1, 2012 | K120679 | SYNAPSE 3D NODULE ANALYSIS | LLZ | Substantially Equivalent | Fujifilm Medical Systems U.S.A, Inc. | accessdata.fda.gov |
| May 8, 2012 | K120637 | SYNAPSE 3D BRAIN PERFUSION | LLZ | Substantially Equivalent | Fujifilm Medical System U.S.A., Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Lung Computed Tomography System, Computer-Aided Detection
- All makers of System, Image Processing, Radiological
- All makers of System, X-Ray, Tomography, Computed
- All makers of Automated Radiological Image Processing Software
Updated May 27, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.