Product Code: JOY FDA class 2 21 CFR 864.5260

Device, Automated Cell-Locating

Hematology

The Device, Automated Cell-Locating is a hematology laboratory instrument designed to automatically identify and locate cells of interest on microscopy slides or within specimens, reducing the time required for manual scanning and assisting laboratory personnel in the review of hematological and cytological preparations. This device is FDA Class 2, indicating moderate risk and requiring 510(k) premarket notification before marketing. It carries product code JOY and is regulated under 21 CFR 864.5260, within the Hematology medical specialty. This device is eligible for third-party 510(k) review.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: JOY
Device Class: FDA class 2
Regulation Number: 864.5260
Medical Specialty: Hematology
Review Panel: HE
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 35 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K243144	X100/X100HT with Full Field Peripheral Blood Smear (PBS) Application	Jun 27, 2025	Substantially Equivalent	Scopio Labs , Ltd.
K221309	AI100 with Shonit	Sep 19, 2023	Substantially Equivalent	Sigtuple Technologies Pvt. , Ltd.
K220013	X100HT with Slide Loader with Full Field Peripheral Blood Smear (PBS) Application	May 03, 2022	Substantially Equivalent	Scopio Labs , Ltd.
K200595	CellaVision DC-1, CellaVision DC-1 PPA	Oct 16, 2020	Substantially Equivalent	CellaVision AB
K201301	X100 with Full Field Peripheral Blood Smear (PBS) Application	Oct 02, 2020	Substantially Equivalent	Scopio Labs , Ltd.
K182062	Sysmex UD-10, Fully Automated Urine Particle Digital Imaging Device	Oct 30, 2018	Substantially Equivalent	Sysmex America, Inc.
K171315	Advanced RBC Application	Aug 01, 2017	Substantially Equivalent	CellaVision AB
K102778	CELLAVISION DM1200 WITH THE BODY FLUID APPLICTION	Sep 16, 2011	Substantially Equivalent	CellaVision AB
K092116	EASYCELL CELL LOCATOR	May 12, 2010	Substantially Equivalent	Medica Corp.
K092868	CELLAVISION DM1200 AUTOMATED HEMATOLOGY ANALYZER, MODEL XU-10127	Nov 20, 2009	Substantially Equivalent	CellaVision AB
K080595	CELLAVISION DM96 WITH THE BODY FLUID APPLICATION	Dec 05, 2008	Substantially Equivalent	CellaVision AB
K071398	SCANVIEW, MODEL SC-300	Oct 04, 2007	Substantially Equivalent	Applied Spectral Imaging , Ltd.
K061602	DUET SYSTEM	Jan 23, 2007	Substantially Equivalent	Bioview , Ltd.
K062755	IKONISCOPE ONCOFISH BLADDER TEST SYSTEM	Jan 04, 2007	Substantially Equivalent	Ikonisys, Inc.
K061392	IKONISCOPE FASTFISH AUTO/AMNIOCYTE TEST SYSTEM	Aug 01, 2006	Substantially Equivalent	Ikonisys, Inc.
K052577	IKONISCOPE FASTFISH AMNIO IMAGING SYSTEM	Jan 24, 2006	Substantially Equivalent	Ikonisys, Inc.
K050840	MODIFICATION TO DUET SYSTEM	Aug 16, 2005	Substantially Equivalent	Bioview , Ltd.
K040591	DUET SYSTEM	Sep 16, 2004	Substantially Equivalent	Bioview , Ltd.
K033840	CELLAVISION DM96 AUTOMATIC HEMATOLOGY ANALYZER	Feb 10, 2004	Substantially Equivalent	CellaVision AB
K030192	DUET SYSTEM	Aug 20, 2003	Substantially Equivalent	Bioview , Ltd.
K003301	DIFFMASTER OCTAVIA AUTOMATIC HEMATOLOGY ANALYZER	Mar 15, 2001	Substantially Equivalent	CellaVision AB
K001420	SLIDESCAN	Aug 30, 2000	Substantially Equivalent	Applied Imaging Corp.
K984188	AUTOMATED CELLULAR IMAGING SYSTEM (ACIS)	Jul 28, 1999	Substantially Equivalent	Chroma Vision Medical Systems, Inc.
K982786	TRACCELL 2000 SLIDE MAPPING SYSTEM	Oct 16, 1998	Substantially Equivalent	Accumed Intl., Inc.
K982301	MICRO21 WITH URINE SEDIMENT ANALYSIS	Aug 07, 1998	Substantially Equivalent	Triangle Biomedical Sciences, Inc.
K980375	WINSCAN AUTOMATED IMAGING SYSTEM	Jun 09, 1998	Substantially Equivalent	Applied Imaging Corp.
K973050	MICRO21 WITH WBC ESTIMATE	Nov 07, 1997	Substantially Equivalent	Triangle Biomedical Sciences, Inc.
K971470	MICRO21 WITH CEREBROSPINAL FLUID	Sep 16, 1997	Substantially Equivalent	Triangle Biomedical Sciences, Inc.
K964689	TRACCELL 2000 SLIDE MAPPING SYSTEM	Aug 18, 1997	Substantially Equivalent	Accumed Intl., Inc.
K970824	MDX 2000, DIGITAL ANALYZER	May 30, 1997	Substantially Equivalent	Shotwell & Carr, Inc.
K960774	MICRO21 WITH ANA	May 22, 1996	Substantially Equivalent	Triangle Biomedical Sciences, Inc.
K960776	MICRO21 WITH RETIC	May 17, 1996	Substantially Equivalent	Triangle Biomedical Sciences, Inc.
K925670	IMS-200	Jul 23, 1993	Substantially Equivalent	Intelligent Medica Imaging, Inc.
K772139	RE-CELL SLIDE RECAP	Jan 05, 1978	Substantially Equivalent	Geometric Data, Div. Smithkline Corp.
K772140	SCANNING SYS., AUTO. COMP., ACS1000	Dec 05, 1977	Substantially Equivalent	Honeywell, Inc.