# Scopio Labs, Ltd.

- Location (FDA's records): Tel Aviv, IL
- FDA decisions: 4 (2020–2025): 3 510(k) clearances and 1 De Novo grant
- Product codes: JOY (3), SAL (1)
- Predicates its devices cite: 4 (3 its own); citations of its devices by later devices: 3 (3 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Medica Corp.: 1 (https://510kreport.com/company/medica)

## Its most-cited devices
- K201301: X100 with Full Field Peripheral Blood Smear (PBS) Application (2020), cited by 2
- K220013: X100HT with Slide Loader with Full Field Peripheral Blood Smear (PBS) Application (2022), cited by 1

## Recent decisions
- K243144: X100/X100HT with Full Field Peripheral Blood Smear (PBS) Application (Jun 27, 2025)
- DEN230034: X100 with Full Field Bone Marrow Aspirate (BMA) Application 2 X100HT with Full Field Bone Marrow Aspirate (BMA) Application (Mar 22, 2024)
- K220013: X100HT with Slide Loader with Full Field Peripheral Blood Smear (PBS) Application (May 3, 2022)
- K201301: X100 with Full Field Peripheral Blood Smear (PBS) Application (Oct 2, 2020)

Source page: https://510kreport.com/company/scopio-labs