INFINITT DPS

K243449

Infinitt Healthcare Co., Ltd. · cleared 2025-12-09 · product code QKQ · Pathology

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.4)
“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.”
AlgorithmFDA source did not state this
Adaptive (vs locked)FDA source did not state this
PCCPNo
Cybersecurity addressedYes
source quote (p.9)
“Cybersecurity testing for the INFINITT DPS addressed potential security risks and verified adherence to medical device software cybersecurity requirements.”

Validation studies (3)

Bench

n=30 images

endpoints: identical image reproduction (CIEDE2000 metric)

standards: Technical Performance Assessment of Digital Pathology Whole Slide Imaging Devices (April 20, 2016)

Bench

sample size not stated

endpoints: length and area measurement accuracy (±2% or ±5 µm)

standards: Technical Performance Assessment of Digital Pathology Whole Slide Imaging Devices (April 20, 2016)

Bench

sample size not stated

endpoints: image load times (≤5 seconds); interaction latency (≤1 second)

standards: Technical Performance Assessment of Digital Pathology Whole Slide Imaging Devices (April 20, 2016)

Reported performance (3 observations)

accuracyas written: “Measurement Accuracy (Length)”stated without valueCI ±2% or ±5 µm
source quote (p.10)
“All results met the predefined acceptance criteria of ±2% or ±5 µm for length and ±5% for area, confirming measurement accuracy.”
accuracyas written: “Measurement Accuracy (Area)”stated without valueCI ±5%
source quote (p.10)
“All results met the predefined acceptance criteria of ±2% or ±5 µm for length and ±5% for area, confirming measurement accuracy.”
time_to_resultas written: “Interaction Latency”0.48
source quote (p.10)
“WSIs loaded within an average of 2.8 seconds, and all interactions responded within an average of 0.48 seconds, meeting the criteria of ≤5 seconds for load time and ≤1 second for interaction latency.”

Each value carries its own analysis unit and task — never compare or pool across devices. Source: 510(k) summary PDF.

Predicate network

Postmarket — what happened after clearance

0
recalls in product code, 24mo
0
MAUDE reports in code, 12mo
—
vs code's own 3-yr baseline
0
drift signals on this device

Recall and MAUDE counts are product-code-level (reports aren't reliably attributable to one device); a recall is shown as device-attributed only when the recall record itself lists this clearance number. Signals are descriptive observables with sources — never a judgment that the device is unsafe or drifting. Snapshot 2026-07-08.

Reimbursement — how devices like this got paid

Not yet tracked — no payment pathway indexed for this clearance (the reimbursement corpus is a growing seed set).

Applicable FDA guidance — what the submission is measured against

FDA guidance documents and guiding principles applicable to 510(k) AI/ML devices in the Pathology panel. A curated reference index, not legal or regulatory advice — each item states its own status, and a draft is never binding.

Applicability is derived from the device's FDA advisory panel and pathway — cross-cutting guidances apply to every AI/ML device; panel-specific ones are flagged. Titles, dates, and links verified against fda.gov as of July 2026.

Constat Precedent · public FDA/CMS data · descriptive decision-support, not regulatory or reimbursement advice. Share this page: constat.dev/precedent/device/K243449