JOY · Device, Automated Cell-Locating
Hematology · 21 CFR 864.5260 · Class 2
Overview
| Product Code | JOY |
|---|---|
| Device Name | Device, Automated Cell-Locating |
| Regulation | 21 CFR 864.5260 |
| Device Class | Class 2 |
| Review Panel | Hematology |
| 3rd-Party Reviewable | Yes |
Identification
An automated cell-locating device is a device used to locate blood cells on a peripheral blood smear, allowing the operator to identify and classify each cell according to type. (Peripheral blood is blood circulating in one of the body's extremities, such as the arm.)
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (20 of 35)
Showing 20 most recent of 35 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K243144 | X100/X100HT with Full Field Peripheral Blood Smear (PBS) Application | Scopio Labs , Ltd. | Jun 27, 2025 | SESE |
| K221309 | AI100 with Shonit | Sigtuple Technologies Pvt. , Ltd. | Sep 19, 2023 | SESE |
| K220013 | X100HT with Slide Loader with Full Field Peripheral Blood Smear (PBS) Application | Scopio Labs , Ltd. | May 3, 2022 | SESE |
| K200595 | CellaVision DC-1, CellaVision DC-1 PPA | CellaVision AB | Oct 16, 2020 | SESE |
| K201301 | X100 with Full Field Peripheral Blood Smear (PBS) Application | Scopio Labs , Ltd. | Oct 2, 2020 | SESE |
| K182062 | Sysmex UD-10, Fully Automated Urine Particle Digital Imaging Device | Sysmex America, Inc. | Oct 30, 2018 | SESE |
| K171315 | Advanced RBC Application | CellaVision AB | Aug 1, 2017 | SESE |
| K102778 | CELLAVISION DM1200 WITH THE BODY FLUID APPLICTION | CellaVision AB | Sep 16, 2011 | SESE |
| K092116 | EASYCELL CELL LOCATOR | Medica Corp. | May 12, 2010 | SESE |
| K092868 | CELLAVISION DM1200 AUTOMATED HEMATOLOGY ANALYZER, MODEL XU-10127 | CellaVision AB | Nov 20, 2009 | SESE |
| K080595 | CELLAVISION DM96 WITH THE BODY FLUID APPLICATION | CellaVision AB | Dec 5, 2008 | SESE |
| K071398 | SCANVIEW, MODEL SC-300 | Applied Spectral Imaging , Ltd. | Oct 4, 2007 | SESE |
| K061602 | DUET SYSTEM | Bioview , Ltd. | Jan 23, 2007 | SESE |
| K062755 | IKONISCOPE ONCOFISH BLADDER TEST SYSTEM | Ikonisys, Inc. | Jan 4, 2007 | SESE |
| K061392 | IKONISCOPE FASTFISH AUTO/AMNIOCYTE TEST SYSTEM | Ikonisys, Inc. | Aug 1, 2006 | SESE |
| K052577 | IKONISCOPE FASTFISH AMNIO IMAGING SYSTEM | Ikonisys, Inc. | Jan 24, 2006 | SESE |
| K050840 | MODIFICATION TO DUET SYSTEM | Bioview , Ltd. | Aug 16, 2005 | SESE |
| K040591 | DUET SYSTEM | Bioview , Ltd. | Sep 16, 2004 | SESE |
| K033840 | CELLAVISION DM96 AUTOMATIC HEMATOLOGY ANALYZER | CellaVision AB | Feb 10, 2004 | SESE |
| K030192 | DUET SYSTEM | Bioview , Ltd. | Aug 20, 2003 | SESE |
Top Applicants
- CellaVision AB — 7 clearances
- Triangle Biomedical Sciences, Inc. — 5 clearances
- Bioview , Ltd. — 4 clearances
- Ikonisys, Inc. — 3 clearances
- Scopio Labs , Ltd. — 3 clearances
