Infinitt DPS

Q: When was Infinitt DPS cleared by the FDA?

Infinitt DPS (K243449) received a 510(k) decision of Substantially Equivalent on December 9, 2025, 397 days after the submission was received.

Q: What is the product code of K243449?

The FDA product code is QKQ – Digital Pathology Image Viewing And Management Software, a Class II (moderate risk) device regulated under 21 CFR 864.3700.

FDA 510(k) K243449 · Infinitt Healthcare Co., Ltd.

Substantially Equivalent

510(k) numberK243449

Submission

Device name: Infinitt DPS
Applicant: Infinitt Healthcare Co., Ltd.
Seoul, KR
Received: November 7, 2024
Decision date: December 9, 2025
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: QKQ – Digital Pathology Image Viewing And Management Software
Device class: Class II (moderate risk)
Regulation: 21 CFR 864.3700
Specialty: Pathology

Digital pathology image viewing and management software device is a software intended for viewing and management of digital images of scanned surgical pathology slides prepared from formalin-fixed paraffin embedded (FFPE) tissue. It is an aid to the pathologist to review and interpret these digital images for the purposes of primary diagnosis.

Other 510(k)s with product code QKQ

510(k)	Device	Applicant	Decision
K261380	Concentriq AP-DxQKQ · Traditional	Proscia, Inc.	08/05/2026SE
K252762	HALO AP DxQKQ · Traditional	Indica Labs, LLC	11/25/2025SE
K243391	AISight DxQKQ · Traditional	PathAI, Inc.	06/26/2025SE
K250968	PathPresenter Clinical ViewerQKQ · Traditional	Pathpresenter Corporation	06/20/2025SE
K250414	CaloPixQKQ · Traditional	Tribun Health	05/14/2025SE
K242244	Viewer+QKQ · Traditional	Lumea, Inc.	03/14/2025SE
K241273	FullFocusQKQ · Traditional	Paige.Ai, Inc.	01/09/2025SE
K240303	MetaLite DX Digital Pathology SoftwareQKQ · Traditional	Jellox Biotech, Inc.	10/28/2024SE
K233126	aetherSlideQKQ · Traditional	Aetherai Co., Ltd.	05/30/2024SE
K212361	NovoQKQ · Traditional	PathAI, Inc.	08/11/2022SE

More from PathAI, Inc.

510(k)	Device	Decision
K193369	Xelis Dental 2.0LLZ · Traditional	04/14/2020SE
K193498	Infinitt RT PACSLLZ · Traditional	02/13/2020SE
K172803	Infinitt PACS 7.0LLZ · Traditional	10/27/2017SE

Questions and answers

When was Infinitt DPS cleared by the FDA?

Infinitt DPS (K243449) received a 510(k) decision of Substantially Equivalent on December 9, 2025, 397 days after the submission was received.

What is the product code of K243449?

The FDA product code is QKQ – Digital Pathology Image Viewing And Management Software, a Class II (moderate risk) device regulated under 21 CFR 864.3700.