Hematology · 510(k) · 2020
CellaVision DC-1, CellaVision DC-1 PPA
CellaVision AB. Cleared by FDA on 16 October 2020 under submission K200595, product code JOY (device, automated cell-locating). What FDA's record says, in FDA's words.
Device record · K200595
- Device. CellaVision DC-1, CellaVision DC-1 PPADEVICE
- Company. CellaVision AB (SE)COMPANY
- Decision. 16 October 2020, 510(k), substantially equivalent (traditional review); received 6 March 2020DECISION
- Panel. HematologyPANEL
- Product code. JOY, Device, Automated Cell-LocatingCODE
- Regulation. 21 CFR 864.5260, Class IIREG
- Source. FDA database entry · decision document (17 pages)SOURCE
Retrieved · the fields above are FDA's; the statement below was copied from the decision document on that day.
What FDA cleared it for
The Indications for Use statement, verbatim, from the decision document.
CellaVision DC-1 is an automated cell-locating device intended for in-vitro diagnostic use in
What the statement says
Pattern matches on the Indications for Use text. Each line is a fact that the text contains the words, not a finding about the device.
- Mentionsa diagnostic claim
Adverse-event reports in MAUDE, by product code
As of , MAUDE held 18 reports filed against devices carrying product code JOY. That code is shared by every device of this type, not this device alone, and MAUDE reports are submitted by manufacturers, facilities and the public without FDA verification. The latest reports, in the reporter’s words:
28 July 2026 · Malfunction · CellaVision DC-1 with CellaVision DM Software DC-1 Version 7.2 · CellaVision AB · report 3003630693-2026-00003
21 July 2026 · Malfunction · AUTOMATED DIGITAL CELL MORPHOLOGY ANALYZER DI-60 · CELLAVISION AB · report 3003630693-2026-00002
26 June 2026 · Malfunction · AUTOMATED DIGITAL CELL MORPHOLOGY ANALYZER DI-60 · CELLAVISION AB · report 3003630693-2026-00001
A SOFTWARE DEFECT HAS BEEN IDENTIFIED IN CELLAVISION DM SOFTWARE VERSION 7.2.0.7 WHEN USED ON CERTAIN WINDOWS 10 SYSTEMS WITH SIMPLIFIED CHINESE AS THE WINDOWS LANGUAGE DURING SMEAR REVIEW IN THE REVIEW SOFTWARE. THE DEFECT AFFECTS THE INTERPRETATION OF MANUALLY ENTERED PLATELET (PLT) COUNTS FOR THE METHOD "COUNT PLTS PER GRID SQUARE". THE SOFTWARE MAY INCORRECTLY PROCESS NUMERICAL INPUTS DUE TO INPUT METHOD EDITOR (IME) BEHAVIOUR, SPECIFICALLY, THE LAST DIGIT IN MULTI-DIGIT VALUES CAN BE […]
8 October 2025 · Malfunction · AUTOMATED DIGITAL CELL MORPHOLOGY ANALYZER DI-60 · CELLAVISION AB · report 3003630693-2025-00001
DURING ROUTINE OPERATION OF THE DI-60 ANALYZER (IN A LAB IN FRANCE) AN ERROR WAS OBSERVED IN SLIDE IDENTIFICATION. AFTER ANALYZING SLIDE 1 (WITH QR CODE) AND PLACING IT IN THE RETURN POSITION, THE ANALYZER ATTEMPTED TO READ THE BARCODE OF SLIDE 2 (WITHOUT QR CODE) BUT INSTEAD RE-READ THE QR CODE OF SLIDE 1. CONSEQUENTLY, BOTH SLIDES WERE ASSIGNED THE SAME QR CODE. THE ISSUE WAS DISCOVERED BY THE OPERATOR/HEALTHCARE PROFESSIONAL AT THE TIME OF EVENT AND THUS NO INCORRECT RESULTS WERE REPORTED. […]
5 November 2024 · Malfunction · CYTOVISION · LEICA BIOSYSTEMS · report 1419341-2024-00012
ON OCT 8TH THE CUSTOMER REPORTED AN ERROR LOADING & UNLOADING, FAILING TO MOVE TO CORRECT LOCATION ON THE STAGE AND SCANS OF A PREVIOUSLY SCANNED/CAPTURED SLIDE WHEN THE SYSTEM SAYS IT'S ON A SUBSEQUENT SLIDE FOR MATERIAL 23GSLXXXKFXUPG FOR CYTOVISION SN# (B)(6). NO LOSS OF PATIENT DATA.
Where this fits
This page is a record, not medical advice and not a safety rating. It copies FDA's fields and FDA's statement, and lists what the statement's text mentions. Read the labeling before relying on any of it.
More devices under product code JOY, in Hematology, from CellaVision AB, or cleared in 2020. The whole record is at FDA AI-enabled medical devices.
A device's authorized use is a sentence the record can be read against. What Apodicta does on a medical record is that reading: every line of a note, a claim or a report proved to its source or held, before it renders.