Scopio Labs , Ltd.

Name: AI Device Index: FDA-listed AI-enabled medical devices
Creator: AI Device Index
License: https://creativecommons.org/licenses/by/4.0/

3 AI-enabled medical devices from Scopio Labs , Ltd. on FDA's AI-enabled device list, newest first. Includes filings under name variants as submitted to FDA.

Decision	Number	Device	Company	Panel
2025-06-27	K243144	X100/X100HT with Full Field Peripheral Blood Smear (PBS) Application	Scopio Labs , Ltd.	Hematology
2022-05-03	K220013	X100HT with Slide Loader with Full Field Peripheral Blood Smear (PBS) Application	Scopio Labs Ltd.	Hematology
2020-10-02	K201301	X100 with Full Field Peripheral Blood Smear (PBS) Application	Scopio Labs LTD.	Hematology

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