# K221309: AI100 with Shonit

- Pathway: 510(k) (Traditional)
- Applicant: Sigtuple Technologies Pvt., Ltd.
- Decided: Sep 19, 2023 after 502 days
- Product code: JOY (Device, Automated Cell-Locating)
- Device class: 2
- Regulation: 21 CFR 864.5260
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K925670 (1993). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200595: CellaVision DC-1, CellaVision DC-1 PPA, CellaVision AB (2020) Summary page 7.

## Indications for use
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.

Source page: https://510kreport.com/device/K221309
Methodology: https://510kreport.com/methodology