FDA 510(k) Applications for Medical Device Product Code "JOY"
(Device, Automated Cell-Locating)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K964689 | ACCUMED INTL., INC. | TRACCELL 2000 SLIDE MAPPING SYSTEM | 08/18/1997 |
| K982786 | ACCUMED INTL., INC. | TRACCELL 2000 SLIDE MAPPING SYSTEM | 10/16/1998 |
| K001420 | APPLIED IMAGING CORP. | SLIDESCAN | 08/30/2000 |
| K980375 | APPLIED IMAGING CORP. | WINSCAN AUTOMATED IMAGING SYSTEM | 06/09/1998 |
| K071398 | APPLIED SPECTRAL IMAGING, LTD. | SCANVIEW, MODEL SC-300 | 10/04/2007 |
| K030192 | BIOVIEW LTD. | DUET SYSTEM | 08/20/2003 |
| K040591 | BIOVIEW LTD. | DUET SYSTEM | 09/16/2004 |
| K061602 | BIOVIEW LTD. | DUET SYSTEM | 01/23/2007 |
| K050840 | BIOVIEW LTD. | MODIFICATION TO DUET SYSTEM | 08/16/2005 |
| K171315 | Cella Vision AB | Advanced RBC Application | 08/01/2017 |
| K200595 | CellaVision AB | CellaVision DC-1, CellaVision DC-1 PPA | 10/16/2020 |
| K092868 | CELLAVISION AB | CELLAVISION DM1200 AUTOMATED HEMATOLOGY ANALYZER, MODEL XU-10127 | 11/20/2009 |
| K102778 | CELLAVISION AB | CELLAVISION DM1200 WITH THE BODY FLUID APPLICTION | 09/16/2011 |
| K033840 | CELLAVISION AB | CELLAVISION DM96 AUTOMATIC HEMATOLOGY ANALYZER | 02/10/2004 |
| K080595 | CELLAVISION AB | CELLAVISION DM96 WITH THE BODY FLUID APPLICATION | 12/05/2008 |
| K003301 | CELLAVISION AB | DIFFMASTER OCTAVIA AUTOMATIC HEMATOLOGY ANALYZER | 03/15/2001 |
| K984188 | CHROMAVISION MEDICAL SYSTEMS, INC. | AUTOMATED CELLULAR IMAGING SYSTEM (ACIS) | 07/28/1999 |
| K052577 | IKONISYS INC | IKONISCOPE FASTFISH AMNIO IMAGING SYSTEM | 01/24/2006 |
| K061392 | IKONISYS INC | IKONISCOPE FASTFISH AUTO/AMNIOCYTE TEST SYSTEM | 08/01/2006 |
| K062755 | IKONISYS INC | IKONISCOPE ONCOFISH BLADDER TEST SYSTEM | 01/04/2007 |
| K092116 | MEDICA CORP. | EASYCELL CELL LOCATOR | 05/12/2010 |
| K201301 | Scopio Labs LTD. | X100 with Full Field Peripheral Blood Smear (PBS) Application | 10/02/2020 |
| K220013 | Scopio Labs Ltd. | X100HT with Slide Loader with Full Field Peripheral Blood Smear (PBS) Application | 05/03/2022 |
| K970824 | SHOTWELL & CARR, INC. | MDX 2000, DIGITAL ANALYZER | 05/30/1997 |
| K221309 | SigTuple Technologies Pvt. Ltd. | AI100 with Shonit | 09/19/2023 |
| K182062 | Sysmex America, Inc. | Sysmex UD-10, Fully Automated Urine Particle Digital Imaging Device | 10/30/2018 |
| K960774 | TRIANGLE BIOMEDICAL SCIENCES, INC. | MICRO21 WITH ANA | 05/22/1996 |
| K971470 | TRIANGLE BIOMEDICAL SCIENCES, INC. | MICRO21 WITH CEREBROSPINAL FLUID | 09/16/1997 |
| K960776 | TRIANGLE BIOMEDICAL SCIENCES, INC. | MICRO21 WITH RETIC | 05/17/1996 |
| K982301 | TRIANGLE BIOMEDICAL SCIENCES, INC. | MICRO21 WITH URINE SEDIMENT ANALYSIS | 08/07/1998 |
| K973050 | TRIANGLE BIOMEDICAL SCIENCES, INC. | MICRO21 WITH WBC ESTIMATE | 11/07/1997 |
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