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

FDA 510(k) K243144 · Scopio Labs , Ltd.

Substantially Equivalent

510(k) numberK243144

Submission

Device name
X100/X100HT with Full Field Peripheral Blood Smear (PBS) Application
Applicant
Scopio Labs , Ltd.
Tel Aviv, IL
Received
September 30, 2024
Decision date
June 27, 2025
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
JOY – Device, Automated Cell-Locating
Device class
Class II (moderate risk)
Regulation
21 CFR 864.5260
Specialty
Hematology

Other 510(k)s with product code JOY

510(k)DeviceApplicantDecision
K221309AI100 with ShonitJOY · Traditional Sigtuple Technologies Pvt. , Ltd.09/19/2023SE
K220013X100HT with Slide Loader with Full Field Peripheral Blood Smear (PBS) ApplicationJOY · Traditional Scopio Labs , Ltd.05/03/2022SE
K200595CellaVision DC-1, CellaVision DC-1 PPAJOY · Traditional CellaVision AB10/16/2020SE
K201301X100 with Full Field Peripheral Blood Smear (PBS) ApplicationJOY · Traditional Scopio Labs , Ltd.10/02/2020SE
K182062Sysmex UD-10, Fully Automated Urine Particle Digital Imaging DeviceJOY · Traditional Sysmex America, Inc.10/30/2018SE
K171315Advanced RBC ApplicationJOY · Traditional CellaVision AB08/01/2017SE
K102778Cellavision DM1200 with the Body Fluid ApplictionJOY · Traditional CellaVision AB09/16/2011SE
K092116Easycell Cell LocatorJOY · Traditional Medica Corp.05/12/2010SE
K092868Cellavision DM1200 Automated Hematology Analyzer, Model XU-10127JOY · Special CellaVision AB11/20/2009SE
K080595Cellavision DM96 with the Body Fluid ApplicationJOY · Traditional CellaVision AB12/05/2008SE

More from CellaVision AB

510(k)DeviceDecision
K220013X100HT with Slide Loader with Full Field Peripheral Blood Smear (PBS) ApplicationJOY · Traditional 05/03/2022SE
K201301X100 with Full Field Peripheral Blood Smear (PBS) ApplicationJOY · Traditional 10/02/2020SE

Questions and answers

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

X100/X100HT with Full Field Peripheral Blood Smear (PBS) Application (K243144) received a 510(k) decision of Substantially Equivalent on June 27, 2025, 270 days after the submission was received.

What is the product code of K243144?

The FDA product code is JOY – Device, Automated Cell-Locating, a Class II (moderate risk) device regulated under 21 CFR 864.5260.