Automated Cellular Imaging System (Acis)

FDA 510(k) K984188 · Chroma Vision Medical Systems, Inc.

Substantially Equivalent

510(k) numberK984188

Submission

Device name
Automated Cellular Imaging System (Acis)
Applicant
Chroma Vision Medical Systems, Inc.
Flower Mound, TX, US
Received
November 23, 1998
Decision date
July 28, 1999
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
JOY – Device, Automated Cell-Locating
Device class
Class II (moderate risk)
Regulation
21 CFR 864.5260
Specialty
Hematology

Other 510(k)s with product code JOY

510(k)DeviceApplicantDecision
K243144X100/X100HT with Full Field Peripheral Blood Smear (PBS) ApplicationJOY · Traditional Scopio Labs , Ltd.06/27/2025SE
K221309AI100 with ShonitJOY · Traditional Sigtuple Technologies Pvt. , Ltd.09/19/2023SE
K220013X100HT with Slide Loader with Full Field Peripheral Blood Smear (PBS) ApplicationJOY · Traditional Scopio Labs , Ltd.05/03/2022SE
K200595CellaVision DC-1, CellaVision DC-1 PPAJOY · Traditional CellaVision AB10/16/2020SE
K201301X100 with Full Field Peripheral Blood Smear (PBS) ApplicationJOY · Traditional Scopio Labs , Ltd.10/02/2020SE
K182062Sysmex UD-10, Fully Automated Urine Particle Digital Imaging DeviceJOY · Traditional Sysmex America, Inc.10/30/2018SE
K171315Advanced RBC ApplicationJOY · Traditional CellaVision AB08/01/2017SE
K102778Cellavision DM1200 with the Body Fluid ApplictionJOY · Traditional CellaVision AB09/16/2011SE
K092116Easycell Cell LocatorJOY · Traditional Medica Corp.05/12/2010SE
K092868Cellavision DM1200 Automated Hematology Analyzer, Model XU-10127JOY · Special CellaVision AB11/20/2009SE

More from CellaVision AB

510(k)DeviceDecision
K032113Acis (Automated Cellular Imaging System)NOT · Traditional 12/23/2003SE
K012138Modification to Acis (Automated Cellular Imaging System)MYA · Traditional 09/30/2002SE

Questions and answers

When was Automated Cellular Imaging System (Acis) cleared by the FDA?

Automated Cellular Imaging System (Acis) (K984188) received a 510(k) decision of Substantially Equivalent on July 28, 1999, 247 days after the submission was received.

What is the product code of K984188?

The FDA product code is JOY – Device, Automated Cell-Locating, a Class II (moderate risk) device regulated under 21 CFR 864.5260.