Pathology · 510(k) · 2025
INFINITT DPS
Infinitt Healthcare Co., Ltd.. Cleared by FDA on 9 December 2025 under submission K243449, product code QKQ (digital pathology image viewing and management software). What FDA's record says, in FDA's words.
Device record · K243449
- Device. INFINITT DPSDEVICE
- Company. Infinitt Healthcare Co., Ltd. (KR)COMPANY
- Decision. 9 December 2025, 510(k), substantially equivalent (traditional review); received 7 November 2024DECISION
- Panel. PathologyPANEL
- Product code. QKQ, Digital Pathology Image Viewing And Management SoftwareCODE
- Regulation. 21 CFR 864.3700, Class IIREG
- Source. FDA database entry · decision document (13 pages)SOURCE
Retrieved · the fields above are FDA's; the statement below was copied from the decision document on that day.
What FDA cleared it for
The Indications for Use statement, verbatim, from the decision document.
INFINITT DPS is a software device intended for viewing and management of whole slide digital images derived from scanned surgical pathology slides prepared from formalin-fixed, paraffin-embedded (FFPE) tissue. It serves as an aid for pathologists to review and interpret these digital images for the purpose of pathology primary diagnosis. INFINITT DPS is intended for use with Hamamatsu NanoZoomer S360MD scanner and Barco MDPC-8127 display. It is the responsibility of the pathologist to implement appropriate procedures and safeguards that assure the integrity and accuracy of image interpretation when utilizing the INFINITT DPS. The system is not intended for use with frozen sections, cytology, or non-FFPE hematopathology specimens.
The product code's definition, from FDA's classification record. 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.
What the statement says
Pattern matches on the Indications for Use text. Each line is a fact that the text contains the words, not a finding about the device.
- Modalities namedpathology slides
- Mentionsa diagnostic claim
Adverse-event reports in MAUDE, by product code
As of , MAUDE held 0 reports filed against devices carrying product code QKQ. That code is shared by every device of this type, not this device alone, and MAUDE reports are submitted by manufacturers, facilities and the public without FDA verification.
Where this fits
This page is a record, not medical advice and not a safety rating. It copies FDA's fields and FDA's statement, and lists what the statement's text mentions. Read the labeling before relying on any of it.
More devices under product code QKQ, in Pathology, from Infinitt Healthcare Co., Ltd., or cleared in 2025. The whole record is at FDA AI-enabled medical devices.
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