FEops HEARTguideTM, FEops HEARTguideTM ALPACA

Q: What is the product code of K223855?

The FDA product code is QIH – Automated Radiological Image Processing Software, a Class II (moderate risk) device regulated under 21 CFR 892.2050.

FDA 510(k) K223855 · Feops NV

Substantially Equivalent

510(k) numberK223855

Submission

Device name: FEops HEARTguideTM, FEops HEARTguideTM ALPACA
Applicant: Feops NV
Gent-Zwijnaarde, BE
Received: December 23, 2022
Decision date: June 6, 2023
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: QIH – Automated Radiological Image Processing Software
Device class: Class II (moderate risk)
Regulation: 21 CFR 892.2050
Specialty: Radiology

To provide automated radiological image processing and analysis tools. Software implementing artificial intelligence including nonadaptive machine learning algorithms trained with clinical and/or artificial data. In these devices, the algorithm training data typically impacts device performance. Adaptive AI algorithms are not within scope of this product code.

Other 510(k)s with product code QIH

510(k)	Device	Applicant	Decision
K261795	Quicktome Software SuiteQIH · Traditional	Omniscient Neurotechnology Pty, Ltd.	09/10/2026SE
K260879	4DMQIH · Traditional	Invia, LLC	09/10/2026SE
K251417	ReVISION 2QIH · Traditional	Argus Cognitive, Inc.	09/09/2026SE
K260525	NextMR SpineQIH · Traditional	MRI2CT, Inc.	09/04/2026SE
K260811	Heartvue.ProtonQIH · Traditional	Heartvue.ai, Inc.	08/26/2026SE
K261595	Ceevra Reveal 4QIH · Traditional	Ceevra, Inc.	08/25/2026SE
K262127	DS Core CBCT AnatomyQIH · Traditional	Dentsply Sirona	08/21/2026SE
K260584	BoneMRIQIH · Traditional	Mriguidance B.V.	08/21/2026SE
K261641	Lower Limb AI (LLAI)QIH · Traditional	AI Planning Logic, Inc.	08/18/2026SE
K253794	Prostate CoreQIH · Traditional	Lucida Medical, Ltd.	08/10/2026SE

More from Lucida Medical, Ltd.

510(k)	Device	Decision
K250635	FEops HEARTguide Simulation ApplicationQQI · Traditional	11/25/2025SE
K214066	FEops HEARTguideQQI · Traditional	02/25/2022SE

Questions and answers

When was FEops HEARTguideTM, FEops HEARTguideTM ALPACA cleared by the FDA?

FEops HEARTguideTM, FEops HEARTguideTM ALPACA (K223855) received a 510(k) decision of Substantially Equivalent on June 6, 2023, 165 days after the submission was received.

What is the product code of K223855?

The FDA product code is QIH – Automated Radiological Image Processing Software, a Class II (moderate risk) device regulated under 21 CFR 892.2050.