Product code JOY
- Device name
- Device, Automated Cell-Locating
- Medical specialty
- Hematology
- Device class
- 2
- Regulation number
- 864.5260
- Review panel
- HE
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K243144 | X100/X100HT with Full Field Peripheral Blood Smear (PBS) Application | Scopio Labs , Ltd. | 2025-06-27 |
| K221309 | AI100 with Shonit | Sigtuple Technologies Pvt. , Ltd. | 2023-09-19 |
| K220013 | X100HT with Slide Loader with Full Field Peripheral Blood Smear (PBS) Application | Scopio Labs , Ltd. | 2022-05-03 |
| K200595 | CellaVision DC-1, CellaVision DC-1 PPA | CellaVision AB | 2020-10-16 |
| K201301 | X100 with Full Field Peripheral Blood Smear (PBS) Application | Scopio Labs , Ltd. | 2020-10-02 |
| K182062 | Sysmex UD-10, Fully Automated Urine Particle Digital Imaging Device | Sysmex America, Inc. | 2018-10-30 |
| K171315 | Advanced RBC Application | CellaVision AB | 2017-08-01 |
| K102778 | CELLAVISION DM1200 WITH THE BODY FLUID APPLICTION | CellaVision AB | 2011-09-16 |
| K092116 | EASYCELL CELL LOCATOR | Medica Corp. | 2010-05-12 |
| K092868 | CELLAVISION DM1200 AUTOMATED HEMATOLOGY ANALYZER, MODEL XU-10127 | CellaVision AB | 2009-11-20 |
| K080595 | CELLAVISION DM96 WITH THE BODY FLUID APPLICATION | CellaVision AB | 2008-12-05 |
| K071398 | SCANVIEW, MODEL SC-300 | Applied Spectral Imaging , Ltd. | 2007-10-04 |
| K061602 | DUET SYSTEM | Bioview , Ltd. | 2007-01-23 |
| K062755 | IKONISCOPE ONCOFISH BLADDER TEST SYSTEM | Ikonisys, Inc. | 2007-01-04 |
| K061392 | IKONISCOPE FASTFISH AUTO/AMNIOCYTE TEST SYSTEM | Ikonisys, Inc. | 2006-08-01 |
| K052577 | IKONISCOPE FASTFISH AMNIO IMAGING SYSTEM | Ikonisys, Inc. | 2006-01-24 |
| K050840 | MODIFICATION TO DUET SYSTEM | Bioview , Ltd. | 2005-08-16 |
| K040591 | DUET SYSTEM | Bioview , Ltd. | 2004-09-16 |
| K033840 | CELLAVISION DM96 AUTOMATIC HEMATOLOGY ANALYZER | CellaVision AB | 2004-02-10 |
| K030192 | DUET SYSTEM | Bioview , Ltd. | 2003-08-20 |
| K003301 | DIFFMASTER OCTAVIA AUTOMATIC HEMATOLOGY ANALYZER | CellaVision AB | 2001-03-15 |
| K001420 | SLIDESCAN | Applied Imaging Corp. | 2000-08-30 |
| K984188 | AUTOMATED CELLULAR IMAGING SYSTEM (ACIS) | Chroma Vision Medical Systems, Inc. | 1999-07-28 |
| K982786 | TRACCELL 2000 SLIDE MAPPING SYSTEM | Accumed Intl., Inc. | 1998-10-16 |
| K982301 | MICRO21 WITH URINE SEDIMENT ANALYSIS | Triangle Biomedical Sciences, Inc. | 1998-08-07 |
| K980375 | WINSCAN AUTOMATED IMAGING SYSTEM | Applied Imaging Corp. | 1998-06-09 |
| K973050 | MICRO21 WITH WBC ESTIMATE | Triangle Biomedical Sciences, Inc. | 1997-11-07 |
| K971470 | MICRO21 WITH CEREBROSPINAL FLUID | Triangle Biomedical Sciences, Inc. | 1997-09-16 |
| K964689 | TRACCELL 2000 SLIDE MAPPING SYSTEM | Accumed Intl., Inc. | 1997-08-18 |
| K970824 | MDX 2000, DIGITAL ANALYZER | Shotwell & Carr, Inc. | 1997-05-30 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 07350040977194 | CellaVision® Remote Review Single Edition | Cellavision AB | 2026-05-08 |
| 07290118610892 | X100HT System | SCOPIO LABS LTD | 2024-12-01 |
| 07290016630046 | ASI IVD System | APPLIED SPECTRAL IMAGING LTD. | 2024-07-02 |
| 07290018417034 | X100 Digital Scanner | SCOPIO LABS LTD | 2022-12-30 |
| 07290018417072 | X100 Processing Unit (Complete Unit) | SCOPIO LABS LTD | 2022-12-30 |
| 07290018417096 | X100HT Digital Scanner | SCOPIO LABS LTD | 2022-12-30 |
| 07290018417126 | X100HT Processing Unit | SCOPIO LABS LTD | 2022-12-30 |
| 07290018417133 | X100 with Full Field Peripheral Blood Smear Application | SCOPIO LABS LTD | 2022-12-30 |
| 07290018417140 | X100HT with Full Field Peripheral Blood Smear (PBS) Application | SCOPIO LABS LTD | 2022-12-30 |
| 07290016630039 | ASI IVD System | APPLIED SPECTRAL IMAGING LTD. | 2022-03-21 |
| 07350040975107 | CellaVision DC-1 PPA | Cellavision AB | 2020-10-22 |
| 07350040975091 | CellaVision DC-1 | Cellavision AB | 2020-10-22 |
| 00849832013495 | WIN10CPU UPGRADE FOR CAPTURE(INWARRANTY) | Leica Biosystems Richmond, Inc. | 2019-11-09 |
| 00849832013488 | WIN10 CPU UPGRADE FOR GSL(IN WARRANTY) | Leica Biosystems Richmond, Inc. | 2019-11-09 |
| 04987562444779 | Fully Automated Urine Particle Digital Imaging Device UD-10 | SYSMEX CORPORATION | 2018-12-11 |
| 07350040973745 | CellaVision® Advanced RBC Application DM1200 | Cellavision AB | 2018-03-05 |
| 07350040973752 | CellaVision® Advanced RBC Application DM96 | Cellavision AB | 2018-03-05 |
| 07350040973769 | CellaVision® Advanced RBC Application DM9600 | Cellavision AB | 2018-03-05 |
| 07290016630015 | GenASIs™ System | APPLIED SPECTRAL IMAGING LTD. | 2018-01-25 |
| 07290016630008 | GenASIs™ System | APPLIED SPECTRAL IMAGING LTD. | 2017-01-12 |
| 07350040973714 | CellaVision® Remote Review Software version 5.0.x, Non-expiring license | Cellavision AB | 2016-09-23 |
| 07350040974506 | CellaVision® Remote Review Software version 6.0.x, Annual license | Cellavision AB | 2016-09-23 |
| 07350040973707 | CellaVision® Remote Review Software version 5.0.x, Annual license | Cellavision AB | 2016-09-23 |
| 07350040972557 | CellaVision® Body Fluid Application DM1200 | Cellavision AB | 2016-09-20 |
| 07350040974322 | CellaVision® DM9600 | Cellavision AB | 2016-09-20 |
| 07350040972564 | CellaVision® Body Fluid Application DM96 | Cellavision AB | 2016-09-20 |
| 07350040972021 | Automated Digital Morphology Analyzer DI-60 | Cellavision AB | 2016-09-20 |
| 07350040971277 | CellaVision® DM1200 | Cellavision AB | 2016-09-20 |
| 07350040973776 | CellaVision® Body Fluid Application DM9600 | Cellavision AB | 2016-09-20 |
| 07350040970201 | CellaVision® DM96 | Cellavision AB | 2016-09-20 |