Data / Medical devices / United States / FUJIFILM Healthcare Americas Corporation
FUJIFILM Healthcare Americas Corporation: FDA-registered device maker in Durham, NC, United States, 7 510(k) clearances
FUJIFILM Healthcare Americas Corporation is registered with the FDA (registration 3004972322) in Durham, NC, United States. It lists 3 device types. The FDA files 7 510(k) clearances under its listings, the newest dated June 18, 2026. Registered through 2026. FDA data exported November 3, 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
- 3004972322
- Address
- 79 TW Alexander Drive, Building 4501, Durham, NC, United States, 27709
- Owner or operator
- FUJIFILM CORPORATION (8031568)
- Roles
- Manufacturer
- First device listed
- March 28, 2016
- Registered through
- 2026
- Brand names listed
- Synapse CardioVascular, Synapse Enterprise Viewer, Synapse PACS, Synapse PACS 5.X, Synapse PACS 7.5, Synapse PACS 7.6, Synapse PACS 7.X, Synapse Select and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Automated Radiological Image Processing Software | QIH | 2 | Manufacturer | accessdata.fda.gov |
| Computer, Diagnostic, Programmable | DQK | 2 | Manufacturer | accessdata.fda.gov |
| System, Image Processing, Radiological | LLZ | 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 |
|---|---|---|---|---|---|---|
| June 18, 2026 | K261713 | Synapse PACS (7.6.0) | QIH | Substantially Equivalent | FUJIFILM Healthcare Americas Corporation | accessdata.fda.gov |
| June 30, 2025 | K243647 | Synapse PACS (7.5) | QIH | Substantially Equivalent | FUJIFILM Healthcare Americas Corporation | accessdata.fda.gov |
| April 25, 2019 | K183248 | Synapse Enterprise Viewer Version 1.0 | LLZ | Substantially Equivalent | Fujifilm Corporation | accessdata.fda.gov |
| March 26, 2019 | K190232 | Synapse PACS | LLZ | Substantially Equivalent | Fujifilm Corporation | accessdata.fda.gov |
| February 3, 2016 | K160108 | Synapse PACS | LLZ | Substantially Equivalent | Fujifilm Medical Systems U.S.A, Inc. | accessdata.fda.gov |
| August 12, 2015 | K151859 | Synapse Cardiovascular | LLZ | Substantially Equivalent | Fujifilm Medical Systems U.S.A, Inc. | accessdata.fda.gov |
| April 15, 2009 | K083910 | VIDISTAR PACS & DICOM VIEWER SOFTWARE SERVER SOFTWARE SYSTEM, HEART VIEW, STANDALONE VIEWER | LLZ | Substantially Equivalent | Vidistar, LLC | accessdata.fda.gov |
Compare with other makers
- All makers of Automated Radiological Image Processing Software
- All makers of System, Image Processing, Radiological
- All makers of Computer, Diagnostic, Programmable
Updated June 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.