Data / Medical devices / United States / Focalyx Technologies
Focalyx Technologies: FDA-registered device maker in Hialeah, FL, United States, 1 510(k) clearance
Focalyx Technologies is registered with the FDA (registration 3016567400) in Hialeah, FL, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated June 7, 2017. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3016567400
- Address
- 2140 W 68th St Ste 406, Hialeah, FL, United States, 33016
- Owner or operator
- Focalyx Technologies (10062693)
- Roles
- Manufacturer
- First device listed
- March 3, 2020
- Registered through
- 2026
- Brand names listed
- Focalyx Fusion, Smartblate
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| 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 7, 2017 | K170250 | SmartTarget | LLZ | Substantially Equivalent | Smarttarget, Ltd. | 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 23, 2025 | 98137 | Class II | Ongoing | Focalyx Fusion | Software device that is an accessory for image-guided interventional and diagnostic procedures involving prostate has accessories that may not function properly with Windows 10, which may cause patient harm during biopsy or cause treatment/therapy delays, so firm is recommending stop use until device is verified/validated with Windows 11. | accessdata.fda.gov |
Compare with other makers
Updated February 3, 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.