11 devices · 8 companies · 2001 to 2025

Product code JOY: Device, Automated Cell-Locating

11 devices under product code JOY, 2001 to 2025, from 8 companies. Each record carries FDA's decision, the Indications for Use statement verbatim where the public document carries one (6 of 11 here), the regulation, and MAUDE report counts by product code.

Device, Automated Cell-Locating. 21 CFR 864.5260, Class II. MAUDE held 18 adverse-event reports against this product code as of 2026-10-29; reports are unverified and the code is shared by every device of this type.

Retrieved from FDA public records.

Companies with more than one device here

Every device, newest decision first

JOY · 11 devices
DecisionDeviceCompanyPanelFDA
X100/X100HT with Full Field Peripheral Blood SmeK243144 · 510(k)Scopio Labs , Ltd.Hematologydatabase entry
AI100 with ShonitK221309 · 510(k)SigTuple Technologies Pvt. Ltd.Hematologydatabase entry
X100HT with Slide Loader with Full Field PeripheK220013 · 510(k)Scopio Labs Ltd.Hematologydatabase entry
CellaVision DC-1, CellaVision DC-1 PPAK200595 · 510(k)CellaVision ABHematologydatabase entry
X100 with Full Field Peripheral Blood SmearK201301 · 510(k)Scopio Labs LTD.Hematologydatabase entry
Advanced RBC ApplicationK171315 · 510(k)Cella Vision ABHematologydatabase entry
CELLAVISION DM1200 WITH THE BODY FLUID APPLICTIOK102778 · 510(k)CELLAVISION ABHematologydatabase entry
EASYCELL CELL LOCATORK092116 · 510(k)MEDICA CORP.Hematologydatabase entry
CELLAVISION DM96 WITH THE BODY FLUID APPLICATIONK080595 · 510(k)CELLAVISION ABHematologydatabase entry
CELLAVISION DM96 AUTOMATIC HEMATOLOGY ANALYZERK033840 · 510(k)CELLAVISION ABHematologydatabase entry
DIFFMASTER OCTAVIA AUTOMATIC HEMATOLOGY ANALYZERK003301 · 510(k)CELLAVISION ABHematologydatabase entry

Every product code in the record, the whole record of FDA AI-enabled medical devices, or what Apodicta does on a medical record.

Show me on one of my files →

Every device here is authorized for a stated use. See a record read against what it must prove, on your own file.

Show me on my files