Koios DS

Q: When was Koios DS cleared by the FDA?

Koios DS (K212616) received a 510(k) decision of Substantially Equivalent on December 16, 2021, 120 days after the submission was received.

Q: What is the product code of K212616?

The FDA product code is POK – Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer, a Class II (moderate risk) device regulated under 21 CFR 892.2060.

FDA 510(k) K212616 · Koios Medical, Inc.

Substantially Equivalent

510(k) numberK212616

Submission

Device name: Koios DS
Applicant: Koios Medical, Inc.
New York, NY, US
Received: August 18, 2021
Decision date: December 16, 2021
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: POK – Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer
Device class: Class II (moderate risk)
Regulation: 21 CFR 892.2060
Specialty: Radiology

Assist users in characterizing lesions identified on acquired medical images

Other 510(k)s with product code POK

510(k)	Device	Applicant	Decision
K253884	Koios DS (3.8)POK · Traditional	Koios Medical, Inc.	07/02/2026SE
K261519	Sonio SuspectPOK · Special	Sonio	06/04/2026SE
K254161	Automated Aortic Stenosis Software (AutoAS)POK · Traditional	GE Medical Systems Ultrasound & Primary Care…	03/27/2026SE
K251769	RevealAI-LungPOK · Traditional	Precision Medical Ventures, Inc. Dba Revealdx	01/30/2026SE
K252294	Fetal EchoScan (v1.2)POK · Traditional	Brightheart	12/08/2025SE
K250221	StrokeSENS ASPECTS Software ApplicationPOK · Traditional	Circle Cardiovascular Imaging, Inc.	07/01/2025SE
K251071	Fetal EchoScan (v1.1)POK · Special	Brightheart	05/02/2025SE
K243614	Sonio SuspectPOK · Traditional	Sonio	02/21/2025SE
K243294	Brainomix 360 e-ASPECTSPOK · Traditional	Brainomix Limited	02/14/2025SE
K242130	Koios DSPOK · Traditional	Koios Medical, Inc.	11/15/2024SE

More from Koios Medical, Inc.

510(k)	Device	Decision
K253884	Koios DS (3.8)POK · Traditional	07/02/2026SE
K242130	Koios DSPOK · Traditional	11/15/2024SE
K190442	Koios DS for BreastPOK · Traditional	07/03/2019SE

Questions and answers

When was Koios DS cleared by the FDA?

Koios DS (K212616) received a 510(k) decision of Substantially Equivalent on December 16, 2021, 120 days after the submission was received.

What is the product code of K212616?

The FDA product code is POK – Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer, a Class II (moderate risk) device regulated under 21 CFR 892.2060.