Tempus Pixel

K252539

Arterys, Inc. · cleared 2025-09-03 · product code QIH · Radiology

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.4)
“Tempus Pixel software is a medical diagnostic application that displays, processes, stores, and transfers DICOM and non-DICOM medical data.”
Algorithmdeep learning model
source quote (p.8)
“For T1, the contouring of the LV Endo and LV Epi can be obtained automatically using a deep learning model or can be drawn manually by the user.”
Adaptive (vs locked)No
source quote (p.8)
“Machine-based learning models Locked/Static”
PCCPNo
Cybersecurity addressedYes
source quote (p.8)
“Cybersecurity Testing: Cybersecurity activities were completed and associated risks have been appropriately mitigated.”

Validation studies (3)

Bench

n=30 cases

endpoints: 95th percentile deviation (absolute error) between Tempus Pixel inline maps and scanner generated inline maps

Reader study (MRMC)

n=3 other

endpoints: User Needs satisfaction; Quantification of T1/T2 values against expected anatomical/pathological findings

Bench

sample size not stated

endpoints: Meeting acceptance criteria for Unit Tests, Integration Tests, and System Tests

Reported performance (0 observations)

FDA source did not state a quantitative performance metric — non-reporting is itself the signal.

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
3
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 Radiology 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/K252539