Cina-Aspects

Q: When was Cina-Aspects cleared by the FDA?

Cina-Aspects (K233342) received a 510(k) decision of Substantially Equivalent on March 15, 2024, 168 days after the submission was received.

Q: What is the product code of K233342?

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) K233342 · Avicenna.Ai

Substantially Equivalent

510(k) numberK233342

Submission

Device name: Cina-Aspects
Applicant: Avicenna.Ai
La Ciotat, FR
Received: September 29, 2023
Decision date: March 15, 2024
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
K240942	CINA-CSpineQAS · Traditional	09/12/2024SE
K240612	Cina-VcfQFM · Traditional	05/31/2024SE
K233968	CINA-iPEQAS · Traditional	03/13/2024SE
K221716	CinaQAS · Special	11/22/2022SE
K210237	Cina ChestQAS · Traditional	05/19/2021SE
K200855	CinaQAS · Traditional	06/24/2020SE

Questions and answers

When was Cina-Aspects cleared by the FDA?

Cina-Aspects (K233342) received a 510(k) decision of Substantially Equivalent on March 15, 2024, 168 days after the submission was received.

What is the product code of K233342?

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.