Data / Medical devices / United States / FUJIFILM Healthcare Americas Corporation
FUJIFILM Healthcare Americas Corporation: FDA-registered device maker in Lexington, MA, United States, 1 510(k) clearance
FUJIFILM Healthcare Americas Corporation is registered with the FDA (registration 3008491142) in Lexington, MA, United States. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated March 1, 2022. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3008491142
- Address
- 81 Hartwell Ave Ste 100, Lexington, MA, United States, 02421
- Owner or operator
- FUJIFILM Healthcare Americas Corporation (10043450)
- Roles
- Manufacturer
- First device listed
- June 1, 2022
- Registered through
- 2026
- Brand names listed
- Synapse Pathology Software
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Digital Pathology Image Viewing And Management Software | QKQ | 2 | Manufacturer | accessdata.fda.gov |
| Whole Slide Imaging System | PSY | 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 |
|---|---|---|---|---|---|---|
| March 1, 2022 | K210811 | Dynamyx Digital Pathology Software | QKQ | Substantially Equivalent | Inspirata, 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 |
|---|---|---|---|---|---|---|
| October 1, 2013 | 66596 | Class II | Terminated | Digital Pathology System (DPS) Software version 1.1 The Omnyx" Integrated Digital Pathology system, which consists of a whole slide scanner and associated software applications, is a scanning, receiving, storing, managin | There is an issue associated with Digital Pathology System (DPS) Software, in which the annotation tools within the DPS version 1.1 Image Viewer will display incorrect measurements and area calculations for a region of interest on a scanned slide, under certain conditions. | accessdata.fda.gov |
Compare with other makers
- All makers of Whole Slide Imaging System
- All makers of Digital Pathology Image Viewing And Management Software
Updated March 1, 2022. 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.