Panels › Hematology › Product code JOY · Class 2
Device, Automated Cell-Locating
Regulation 864.5260
0510(k)s in 12 months (35 all time)
1recalls in 12 months (4 all time)
4recalls that name a 510(k)
Top companies in JOY
| Company | 510(k)s | Recalls |
|---|---|---|
| CellaVision AB | 7 | 2 |
| Triangle Biomedical Sciences, Inc. | 5 | 0 |
| Bioview , Ltd. | 4 | 0 |
| Ikonisys, Inc. | 3 | 0 |
| Scopio Labs , Ltd. | 3 | 0 |
| Accumed Intl., Inc. | 2 | 0 |
| Applied Imaging Corp. | 2 | 0 |
| Applied Spectral Imaging , Ltd. | 1 | 0 |
| Chroma Vision Medical Systems, Inc. | 1 | 0 |
| Geometric Data, Div. Smithkline Corp. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 27, 2025 | K243144 | X100/X100HT with Full Field Peripheral Blood Smear (PBS) Application Scopio Labs , Ltd., IL | JOY |
| Sep 19, 2023 | K221309 | AI100 with Shonit Sigtuple Technologies Pvt. , Ltd., IN | JOY |
| May 3, 2022 | K220013 | X100HT with Slide Loader with Full Field Peripheral Blood Smear (PBS) Application Scopio Labs , Ltd., IL | JOY |
| Oct 16, 2020 | K200595 | CellaVision DC-1, CellaVision DC-1 PPA CellaVision AB, SE | JOY |
| Oct 2, 2020 | K201301 | X100 with Full Field Peripheral Blood Smear (PBS) Application Scopio Labs , Ltd., IL | JOY |
| Oct 30, 2018 | K182062 | Sysmex UD-10, Fully Automated Urine Particle Digital Imaging Device Sysmex America, Inc. | JOY |
| Aug 1, 2017 | K171315 | Advanced RBC Application CellaVision AB, SE | JOY |
| Sep 16, 2011 | K102778 | CELLAVISION DM1200 WITH THE BODY FLUID APPLICTION CellaVision AB | JOY |
| May 12, 2010 | K092116 | EASYCELL CELL LOCATOR Medica Corp. | JOY |
| Nov 20, 2009 | K092868 | CELLAVISION DM1200 AUTOMATED HEMATOLOGY ANALYZER, MODEL XU-10127 CellaVision AB | JOY |
| Dec 5, 2008 | K080595 | CELLAVISION DM96 WITH THE BODY FLUID APPLICATION CellaVision AB | JOY |
| Oct 4, 2007 | K071398 | SCANVIEW, MODEL SC-300 Applied Spectral Imaging , Ltd., IL | JOY |
| Jan 23, 2007 | K061602 | DUET SYSTEM Bioview , Ltd., IL | JOY |
| Jan 4, 2007 | K062755 | IKONISCOPE ONCOFISH BLADDER TEST SYSTEM Ikonisys, Inc. | JOY |
| Aug 1, 2006 | K061392 | IKONISCOPE FASTFISH AUTO/AMNIOCYTE TEST SYSTEM Ikonisys, Inc. | JOY |
| Jan 24, 2006 | K052577 | IKONISCOPE FASTFISH AMNIO IMAGING SYSTEM Ikonisys, Inc. | JOY |
| Aug 16, 2005 | K050840 | MODIFICATION TO DUET SYSTEM Bioview , Ltd., IL | JOY |
| Sep 16, 2004 | K040591 | DUET SYSTEM Bioview , Ltd., IL | JOY |
| Feb 10, 2004 | K033840 | CELLAVISION DM96 AUTOMATIC HEMATOLOGY ANALYZER CellaVision AB | JOY |
| Aug 20, 2003 | K030192 | DUET SYSTEM Bioview , Ltd., IL | JOY |
| Mar 15, 2001 | K003301 | DIFFMASTER OCTAVIA AUTOMATIC HEMATOLOGY ANALYZER CellaVision AB | JOY |
| Aug 30, 2000 | K001420 | SLIDESCAN Applied Imaging Corp. | JOY |
| Jul 28, 1999 | K984188 | AUTOMATED CELLULAR IMAGING SYSTEM (ACIS) Chroma Vision Medical Systems, Inc. | JOY |
| Oct 16, 1998 | K982786 | TRACCELL 2000 SLIDE MAPPING SYSTEM Accumed Intl., Inc. | JOY |
| Aug 7, 1998 | K982301 | MICRO21 WITH URINE SEDIMENT ANALYSIS Triangle Biomedical Sciences, Inc. | JOY |
| Jun 9, 1998 | K980375 | WINSCAN AUTOMATED IMAGING SYSTEM Applied Imaging Corp. | JOY |
| Nov 7, 1997 | K973050 | MICRO21 WITH WBC ESTIMATE Triangle Biomedical Sciences, Inc. | JOY |
| Sep 16, 1997 | K971470 | MICRO21 WITH CEREBROSPINAL FLUID Triangle Biomedical Sciences, Inc. | JOY |
| Aug 18, 1997 | K964689 | TRACCELL 2000 SLIDE MAPPING SYSTEM Accumed Intl., Inc. | JOY |
| May 30, 1997 | K970824 | MDX 2000, DIGITAL ANALYZER Shotwell & Carr, Inc. | JOY |
| May 22, 1996 | K960774 | MICRO21 WITH ANA Triangle Biomedical Sciences, Inc. | JOY |
| May 17, 1996 | K960776 | MICRO21 WITH RETIC Triangle Biomedical Sciences, Inc. | JOY |
| Jul 23, 1993 | K925670 | IMS-200 Intelligent Medica Imaging, Inc. | JOY |
| Jan 5, 1978 | K772139 | RE-CELL SLIDE RECAP Geometric Data, Div. Smithkline Corp. | JOY |
| Dec 5, 1977 | K772140 | SCANNING SYS., AUTO. COMP., ACS1000 Honeywell, Inc. | JOY |
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