Data / Medical devices / Japan / FUJIFILM Corporation Medical Systems Research & Development Center Kashiwa
FUJIFILM Corporation Medical Systems Research & Development Center Kashiwa: FDA-registered device maker in KASHIWA-SHI Chiba, Japan, 24 510(k) clearances
FUJIFILM Corporation Medical Systems Research & Development Center Kashiwa is registered with the FDA (registration 3018423337) in KASHIWA-SHI Chiba, Japan. It lists 4 device types. The FDA files 24 510(k) clearances under its listings, the newest dated September 18, 2026. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3018423337
- Address
- 2-1, Shintoyofuta, KASHIWA-SHI Chiba, Japan, 277-0804
- Owner or operator
- FUJIFILM Corporation (10081521)
- Roles
- Manufacturer
- First device listed
- April 22, 2021
- Registered through
- 2026
- Brand names listed
- APERTO LUCENT MRI System, APERTO Lucent MRI System, ECHELON OVAL MRI SYSTEM, ECHELON Synergy, ECHELON Synergy MRI System, ECHELON Synergy V10 MRI system, Echelon Rapid Cardiac/Hip Coil, FCT iStream Phase 1 and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Coil, Magnetic Resonance, Specialty | MOS | 2 | Manufacturer | accessdata.fda.gov |
| System, Nuclear Magnetic Resonance Imaging | LNH | 2 | Manufacturer | accessdata.fda.gov |
| System, Nuclear Magnetic Resonance Spectroscopic | LNI | 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 |
|---|---|---|---|---|---|---|
| September 18, 2026 | K261229 | SCENARIA View Phase 6.0 | JAK | Substantially Equivalent | Fujifilm Corporation | accessdata.fda.gov |
| September 16, 2026 | K261283 | APERTO Lucent MRI System | LNH | Substantially Equivalent | Fujifilm Corporation | accessdata.fda.gov |
| September 4, 2026 | K253836 | FCT iStream Phase 2 | JAK | Substantially Equivalent | Fujifilm Corporation | accessdata.fda.gov |
| April 6, 2026 | K253862 | APERTO Lucent MRI System | LNH | Substantially Equivalent | Fujifilm Corporation | accessdata.fda.gov |
| September 17, 2025 | K251386 | ECHELON Synergy | LNH | Substantially Equivalent | Fujifilm Corporation | accessdata.fda.gov |
| May 20, 2025 | K250370 | SCENARIA View Phase 5.0 | JAK | Substantially Equivalent | Fujifilm Corporation | accessdata.fda.gov |
| August 13, 2024 | K241429 | ECHELON Synergy MRI System | LNH | Substantially Equivalent | Fujifilm Healthcare Corporation | accessdata.fda.gov |
| May 10, 2024 | K233629 | APERTO Lucent MRI System | LNH | Substantially Equivalent | FUJIFILM Healthcare Americas Corporation | accessdata.fda.gov |
| May 3, 2024 | K233687 | ECHELON Synergy V10.0 | LNH | Substantially Equivalent | FUJIFILM Healthcare Americas Corporation | accessdata.fda.gov |
| April 26, 2024 | K233583 | FCT iSTREAM Phase 1 | JAK | Substantially Equivalent | FUJIFILM Healthcare Americas Corporation | accessdata.fda.gov |
| April 12, 2024 | K240571 | OASIS MRI System | LNH | Substantially Equivalent | Fujifilm Healthcare Corporation | accessdata.fda.gov |
| July 13, 2023 | K223426 | ECHELON Synergy MRI system | LNH | Substantially Equivalent | Fujifilm Healthcare Corporation | accessdata.fda.gov |
| January 26, 2023 | K221619 | ECHELON Oval V6.2 MRI System | LNH | Substantially Equivalent | Fujifilm Healthcare Corporation | accessdata.fda.gov |
| May 23, 2022 | K213829 | SCENARIA View | JAK | Substantially Equivalent | Fujifilm Healthcare Corporation | accessdata.fda.gov |
| October 7, 2021 | K211406 | OASIS MRI System | LNH | Substantially Equivalent | Hitachi Healthcare Americas | accessdata.fda.gov |
| October 21, 2020 | K202030 | OASIS MRI System | LNH | Substantially Equivalent | Hitachi Healthcare Americas | accessdata.fda.gov |
| September 13, 2019 | K190841 | SCENARIA View | JAK | Substantially Equivalent | Hitachi Healthcare Americas | accessdata.fda.gov |
| March 3, 2017 | K163528 | HITACHI Supria Whole-body X-ray CT System Phase 3 | JAK | Substantially Equivalent | Hitachi Medical Systems America, Inc. | accessdata.fda.gov |
| September 30, 2015 | K150565 | Supria Whole-body X-ray CT System | JAK | Substantially Equivalent | Hitachi Medical Systems America, Inc. | accessdata.fda.gov |
| May 1, 2012 | K113145 | ECHELON OVAL MRI SYSTEM | LNH | Substantially Equivalent | Hitachi Medical Systems America, Inc. | accessdata.fda.gov |
| February 11, 2008 | K080062 | OASIS RAPID BREAST COIL, MODEL MR-IBC-120 AND OASIS RAPID NV COIL, MODEL MR-NVC-120 | MOS | Substantially Equivalent | Hitachi Medical Systems America, Inc. | accessdata.fda.gov |
| January 18, 2008 | K073310 | OASIS CTL COIL, OD FLEXIBLE BODY COIL (L AND XL), AND RAPID FOOT COIL | MOS | Substantially Equivalent | Hitachi Medical Corp. | accessdata.fda.gov |
| September 21, 2007 | K072279 | MAGNETIC RESONANCE DIAGNOSTIC DEVICE | LNH | Substantially Equivalent | Hitachi Medical Systems America, Inc. | accessdata.fda.gov |
| December 12, 2006 | K063513 | ECHELON MR-RCC-150 CARDIAC COIL | MOS | Substantially Equivalent | Hitachi Medical Systems America, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| December 8, 2017 | 79439 | Class II | Terminated | MHI-TM2000 Linear Accelerator System Product Usage: MHI-TM2000 Linear Accelerator System is intended for radiation therapy of lesions, tumors and conditions anywhere in the body where radiation treatment is indicated. | Due to a system controller software anomaly, the patient positioning deviation correction may not be applied and may result in the wrong part of the patient being irradiated. | accessdata.fda.gov |
Compare with other makers
- All makers of System, X-Ray, Tomography, Computed
- All makers of System, Nuclear Magnetic Resonance Imaging
- All makers of Coil, Magnetic Resonance, Specialty
- All makers of System, Nuclear Magnetic Resonance Spectroscopic
Updated September 18, 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.