Data / Medical devices / Israel / Scopio Labs Ltd.
Scopio Labs Ltd.: FDA-registered device maker in Tel Aviv, Israel, 3 510(k) clearances
Scopio Labs Ltd. is registered with the FDA (registration 3018182832) in Tel Aviv, Israel. It lists 1 device type. The FDA files 3 510(k) clearances under its listings, the newest dated June 27, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3018182832
- Address
- 10 Hasharon St., Tel Aviv, Israel, 6618502
- Owner or operator
- Scopio Labs Ltd. (10080474)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- February 4, 2021
- Registered through
- 2026
- Brand names listed
- X100 / X100HT with Full Field Peripheral Blood Smear (PBS) Application, X100 with Full Field Peripheral Blood Smear (PBS) Application, X100HT with Full Field Peripheral Blood Smear (PBS) Application
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Device, Automated Cell-Locating | JOY | 2 | Complaint file establishment, 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 27, 2025 | K243144 | X100/X100HT with Full Field Peripheral Blood Smear (PBS) Application | JOY | Substantially Equivalent | Scopio Labs , Ltd. | accessdata.fda.gov |
| May 3, 2022 | K220013 | X100HT with Slide Loader with Full Field Peripheral Blood Smear (PBS) Application | JOY | Substantially Equivalent | Scopio Labs , Ltd. | accessdata.fda.gov |
| October 2, 2020 | K201301 | X100 with Full Field Peripheral Blood Smear (PBS) Application | JOY | Substantially Equivalent | Scopio Labs , Ltd. | accessdata.fda.gov |
Compare with other makers
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.