Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in IsraelLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 4 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Scopio Labs Ltd. with 3 510(k) clearances and 3 AI-enabled devices. The most recent is a 510(k) clearance dated Jun 27, 2025: X100/X100HT with Full Field Peripheral Blood Smear (PBS) Application.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Jun 27, 2025 | X100/X100HT with Full Field Peripheral Blood Smear (PBS) ApplicationK243144 · JOY | 510(k) clearances |
| Jun 27, 2025 | X100/X100HT with Full Field Peripheral Blood Smear (PBS) ApplicationK243144 · Hematology | AI-enabled devices |
| Mar 22, 2024 | X100 with Full Field Bone Marrow Aspirate (BMA) Application 2 X100HT with Full Field Bone Marrow Aspirate (BMA) ApplicationDEN230034 · SAL | 510(k) clearances |
| May 3, 2022 | X100HT with Slide Loader with Full Field Peripheral Blood Smear (PBS) ApplicationK220013 · JOY | 510(k) clearances |
| May 3, 2022 | X100HT with Slide Loader with Full Field Peripheral Blood Smear (PBS) ApplicationK220013 · Hematology | AI-enabled devices |
| Oct 2, 2020 | X100 with Full Field Peripheral Blood Smear (PBS) ApplicationK201301 · JOY | 510(k) clearances |
| Oct 2, 2020 | X100 with Full Field Peripheral Blood Smear (PBS) ApplicationK201301 · Hematology | AI-enabled devices |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
