Data / Medical devices / Device, Automated Cell-Locating
Device, Automated Cell-Locating (JOY): 10 FDA-registered makers in 4 countries
10 establishments in 4 countries are registered with the FDA to make Device, Automated Cell-Locating (product code JOY, Class 2, 21 CFR 864.5260). 8 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 35 510(k) clearances under this code, the latest on June 27, 2025, and lists 4 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- JOY
- Device class
- 2
- Regulation
- 864.5260
- Medical specialty
- Hematology
Makers by country
| Country | Makers |
|---|---|
| United States | 3 |
| Israel | 3 |
| Sweden | 2 |
| Japan | 2 |
Makers of Device, Automated Cell-Locating
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Cellavision AB | LUND Skane, Sweden | Complaint file establishment, Exporter to the US, Manufacturer, Specification developer | 6 | October 16, 2020 | 0 | 2 | 0 | api.fda.gov |
| Ikonisys, Inc | New Haven, CT, United States | Manufacturer | 3 | January 4, 2007 | 0 | 0 | 0 | api.fda.gov |
| Scopio Labs Ltd. | Tel Aviv, Israel | Complaint file establishment, Manufacturer | 3 | June 27, 2025 | 0 | 0 | 0 | api.fda.gov |
| Applied Spectral Imaging, Ltd. | Yokneam Northern, Israel | Manufacturer | 1 | October 4, 2007 | 0 | 0 | 0 | api.fda.gov |
| Sysmex Corporation Techno Park | KOBE Hyogo, Japan | Specification developer | 1 | October 30, 2018 | 0 | 0 | 0 | api.fda.gov |
| SYSMEX CORPORATION i-SQUARE | Kakogawa Hyogo, Japan | Manufacturer | 1 | October 30, 2018 | 0 | 0 | 0 | api.fda.gov |
| Sysmex America, Inc. | Buffalo Grove, IL, United States | Contract manufacturer, Manufacturer | 1 | October 30, 2018 | 0 | 0 | 0 | api.fda.gov |
| Sysmex America, Inc. - Vernon Hills | Vernon Hills, IL, United States | Contract manufacturer, Manufacturer | 1 | October 30, 2018 | 0 | 0 | 0 | api.fda.gov |
| Bioview Ltd. | REHOVOT Central, Israel | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Kitron AB | Jonkoping, Sweden | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated June 27, 2025. 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.