FDA 510(k)

X100/X100HT with Full Field Peripheral Blood Smear (PBS) Application

K-Number: K243144 · 2025-06-27

Decision Date2025-06-27

Product CodeJOY

Advisory CommitteeHE

DecisionSubstantially Equivalent

Device Summary

X100/X100HT with Full Field Peripheral Blood Smear (PBS) Application is a medical device manufactured by Scopio Labs , Ltd.. It received FDA 510(k) clearance on 2025-06-27 under approval number K243144. The device is classified under product code JOY. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the X100/X100HT with Full Field Peripheral Blood Smear (PBS) Application?

X100/X100HT with Full Field Peripheral Blood Smear (PBS) Application is a medical device that received FDA 510(k) clearance on 2025-06-27. It is manufactured by Scopio Labs , Ltd.. The 510(k) number is K243144.

When was X100/X100HT with Full Field Peripheral Blood Smear (PBS) Application approved by the FDA?

X100/X100HT with Full Field Peripheral Blood Smear (PBS) Application received FDA 510(k) clearance on 2025-06-27, under approval number K243144.

What company makes X100/X100HT with Full Field Peripheral Blood Smear (PBS) Application?

X100/X100HT with Full Field Peripheral Blood Smear (PBS) Application is manufactured by Scopio Labs , Ltd..

What is the FDA product code for X100/X100HT with Full Field Peripheral Blood Smear (PBS) Application?

The FDA product code for X100/X100HT with Full Field Peripheral Blood Smear (PBS) Application is JOY.

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Related PubMed Literature

PMID: 41501972 First Application of an Eddy-Scale Hemolysis Model to the Food and Drug Administration Nozzle Using Computational Fluid Dynamics. ASAIO journal (American Society for Artificial Internal Organs : 1992) (2026) PMID: 37948287 TCCC Decision Support With Machine Learning Prediction of Hemorrhage Risk, Shock Probability. Military medicine (2023) PMID: 26054096 Cardiovascular devices; reclassification of nonroller-type cardiopulmonary bypass blood pumps for cardiopulmonary and circulatory bypass; effective date of requirement for premarket approval for nonroller-type cardiopulmonary bypass blood pumps for temporary ventricular support. Final order. Federal register (2015)

Other Devices by Scopio Labs , Ltd.

K201301X100 with Full Field Peripheral Blood Smear (PBS) Application K220013X100HT with Slide Loader with Full Field Peripheral Blood Smear (PBS) Application DEN230034X100 with Full Field Bone Marrow Aspirate (BMA) Application 2 X100HT with Full Field Bone Marrow Aspirate (BMA) Application

Related Devices (Code: JOY)

K171315Advanced RBC ApplicationCellaVision AB K182062Sysmex UD-10, Fully Automated Urine Particle Digital Imaging DeviceSysmex America, Inc. K200595CellaVision DC-1, CellaVision DC-1 PPACellaVision AB K201301X100 with Full Field Peripheral Blood Smear (PBS) ApplicationScopio Labs , Ltd. K220013X100HT with Slide Loader with Full Field Peripheral Blood Smear (PBS) ApplicationScopio Labs , Ltd. K221309AI100 with ShonitSigtuple Technologies Pvt. , Ltd.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.