Cleared Traditional

K242130 - Koios DS
(FDA 510(k) Clearance)

K242130 · Koios Medical, Inc. · Radiology

Nov 2024

Decision

116d

Days

Class 2

Risk

K242130 is an FDA 510(k) clearance for the Koios DS. This device is classified as a Computer-assisted Diagnostic Software For Lesions Suspicious For Cancer (Class II — Special Controls, product code POK).

Submitted by Koios Medical, Inc. (New York, US). The FDA issued a Cleared decision on November 15, 2024, 116 days after receiving the submission on July 22, 2024.

This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.2060. Assist Users In Characterizing Lesions Identified On Acquired Medical Images.

Submission Details

510(k) Number	K242130 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 22, 2024
Decision Date	November 15, 2024
Days to Decision	116 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF

Device Classification

Product Code	POK — Computer-assisted Diagnostic Software For Lesions Suspicious For Cancer
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 892.2060
Definition	Assist Users In Characterizing Lesions Identified On Acquired Medical Images