Hematology · 510(k) · 2023
AI100 with Shonit
SigTuple Technologies Pvt. Ltd.. Cleared by FDA on 19 September 2023 under submission K221309, product code JOY (device, automated cell-locating). What FDA's record says, in FDA's words.
Device record · K221309
- Device. AI100 with ShonitDEVICE
- Company. SigTuple Technologies Pvt. Ltd. (IN)COMPANY
- Decision. 19 September 2023, 510(k), substantially equivalent (traditional review); received 5 May 2022DECISION
- Panel. HematologyPANEL
- Product code. JOY, Device, Automated Cell-LocatingCODE
- Regulation. 21 CFR 864.5260, Class IIREG
- Source. FDA database entry · decision document (15 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.
AI100 with ShonitTM is a cell locating device intended for in-vitro diagnostic use in clinical laboratories. AI100 with ShonitTM is intended for differential count of White Blood Cells (WBC), characterization of Red Blood Cells (RBC) morphology and Platelet morphology. It automatically locates blood cells on peripheral blood smears and presents images of the blood cells for review. A skilled operator, trained in the use of the device and in the review of blood cells, identifies and classifies each cell according to type.
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.
- Mentionsdetection or identification of findings
- 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, or cleared in 2023. 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.