510(k) · Hematology

AI100 with Shonit

by SigTuple Technologies Pvt. Ltd.

AI100 with Shonit is an AI-enabled medical device from SigTuple Technologies Pvt. Ltd. that the U.S. FDA cleared through 510(k) K221309 on September 19, 2023. Its lead review panel is Hematology and its primary product code is JOY (Device, Automated Cell-Locating).

See also all FDA AI clearances in 2023, top hematology AI devices.

Key facts

Submission numberK221309
Pathway510(k)
Date of final decision
Company (FDA list)SigTuple Technologies Pvt. Ltd.
Lead review panelHematology
Primary product codeJOY — Device, Automated Cell-Locating
Applicant (openFDA)Sigtuple Technologies Pvt. , Ltd.
Applicant locationBangalore, IN
Device classClass 2
Regulation number21 CFR 864.5260
Decision codeSESE
Submission typeTraditional

Source: FDA AI-Enabled Medical Devices list and openFDA.

What this means

A 510(k) is a premarket submission showing the device is substantially equivalent to a legally marketed predicate device. A cleared 510(k) means FDA agreed with that equivalence. AI100 with Shonit went through this pathway (K221309).

openFDA lists it as a Class 2 device under 21 CFR 864.5260. Class II devices are moderate risk and are subject to general and special controls.

Product code JOY covers 11 devices on the FDA AI list. By decision date, this device is #10 of 11 under that code. SigTuple Technologies Pvt. Ltd. has 1 AI-enabled device on the list, and the Hematology panel accounts for 22 in total.

Being on this list doesn't describe how well the device works clinically. Check the FDA record for its indications for use.

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