JOY · Class II · 21 CFR 864.5260

FDA Product Code JOY: Device, Automated Cell-locating

Leading manufacturers include CellaVision AB, Triangle Biomedical Sciences, Inc. and Bioview , Ltd..

35
Total
35
Cleared
158d
Avg days
1977
Since
Stable submission activity - 1 submissions in the last 2 years
Review times increasing: avg 270d recently vs 155d historically

FDA 510(k) Cleared Device, Automated Cell-locating Devices (Product Code JOY)

35 devices
1–24 of 35
Cleared Jun 27, 2025
X100/X100HT with Full Field Peripheral Blood Smear (PBS) Application
K243144
Scopio Labs , Ltd.
Hematology · 270d
Cleared Sep 19, 2023
AI100 with Shonit
K221309
Sigtuple Technologies Pvt. , Ltd.
Hematology · 502d
Cleared May 03, 2022
X100HT with Slide Loader with Full Field Peripheral Blood Smear (PBS) Application
K220013
Scopio Labs , Ltd.
Hematology · 119d
Cleared Oct 16, 2020
CellaVision DC-1, CellaVision DC-1 PPA
K200595
CellaVision AB
Hematology · 224d
Cleared Oct 02, 2020
X100 with Full Field Peripheral Blood Smear (PBS) Application
K201301
Scopio Labs , Ltd.
Hematology · 140d
Cleared Oct 30, 2018
Sysmex UD-10, Fully Automated Urine Particle Digital Imaging Device
K182062
Sysmex America, Inc.
Hematology · 90d
Cleared Aug 01, 2017
Advanced RBC Application
K171315
CellaVision AB
Hematology · 89d
Cleared Sep 16, 2011
CELLAVISION DM1200 WITH THE BODY FLUID APPLICTION
K102778
CellaVision AB
Hematology · 357d
Cleared May 12, 2010
EASYCELL CELL LOCATOR
K092116
Medica Corp.
Hematology · 302d
Cleared Nov 20, 2009
CELLAVISION DM1200 AUTOMATED HEMATOLOGY ANALYZER, MODEL XU-10127
K092868
CellaVision AB
Hematology · 63d
Cleared Dec 05, 2008
CELLAVISION DM96 WITH THE BODY FLUID APPLICATION
K080595
CellaVision AB
Hematology · 277d
Cleared Oct 04, 2007
SCANVIEW, MODEL SC-300
K071398
Applied Spectral Imaging , Ltd.
Hematology · 136d
Cleared Jan 23, 2007
DUET SYSTEM
K061602
Bioview , Ltd.
Hematology · 229d
Cleared Jan 04, 2007
IKONISCOPE ONCOFISH BLADDER TEST SYSTEM
K062755
Ikonisys, Inc.
Hematology · 112d
Cleared Aug 01, 2006
IKONISCOPE FASTFISH AUTO/AMNIOCYTE TEST SYSTEM
K061392
Ikonisys, Inc.
Hematology · 74d
Cleared Jan 24, 2006
IKONISCOPE FASTFISH AMNIO IMAGING SYSTEM
K052577
Ikonisys, Inc.
Hematology · 127d
Cleared Aug 16, 2005
MODIFICATION TO DUET SYSTEM
K050840
Bioview , Ltd.
Hematology · 137d
Cleared Sep 16, 2004
DUET SYSTEM
K040591
Bioview , Ltd.
Hematology · 192d
Cleared Feb 10, 2004
CELLAVISION DM96 AUTOMATIC HEMATOLOGY ANALYZER
K033840
CellaVision AB
Hematology · 62d
Cleared Aug 20, 2003
DUET SYSTEM
K030192
Bioview , Ltd.
Hematology · 211d
Cleared Mar 15, 2001
DIFFMASTER OCTAVIA AUTOMATIC HEMATOLOGY ANALYZER
K003301
CellaVision AB
Hematology · 146d
Cleared Aug 30, 2000
SLIDESCAN
K001420
Applied Imaging Corp.
Hematology · 117d
Cleared Jul 28, 1999
AUTOMATED CELLULAR IMAGING SYSTEM (ACIS)
K984188
Chroma Vision Medical Systems, Inc.
Hematology · 247d
Cleared Oct 16, 1998
TRACCELL 2000 SLIDE MAPPING SYSTEM
K982786
Accumed Intl., Inc.
Hematology · 67d

About Product Code JOY - Regulatory Context

510(k) Submission Activity

35 total 510(k) submissions under product code JOY since 1977, with 35 receiving FDA clearance (average review time: 158 days).

Submission volume has remained relatively stable over the observed period, with 1 submissions in the last 24 months.

FDA 510(k) Review Time - JOY Product Code

Recent submissions under JOY have taken an average of 270 days to reach a decision - up from 155 days historically. Manufacturers should account for longer review timelines in current project planning.

JOY devices are reviewed by the Hematology panel. Browse all Hematology devices →