K243144 is an FDA 510(k) clearance for the X100/X100HT with Full Field Peripheral Blood Smear (PBS) Application. This device is classified as a Device, Automated Cell-locating (Class II - Special Controls, product code JOY).
Submitted by Scopio Labs , Ltd. (Tel Aviv, IL). The FDA issued a Cleared decision on June 27, 2025, 270 days after receiving the submission on September 30, 2024.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.5260.
| 510(k) Number | K243144 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 30, 2024 |
| Decision Date | June 27, 2025 |
| Days to Decision | 270 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | Summary PDF |
| Product Code | JOY - Device, Automated Cell-locating |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.5260 |