Tempus Pixel
K252539Arterys, Inc. · cleared 2025-09-03 · product code QIH · Radiology
Premarket evidence — what FDA accepted
source quote (p.4)
“Tempus Pixel software is a medical diagnostic application that displays, processes, stores, and transfers DICOM and non-DICOM medical data. It provides the capability to store images and patient information, and perform filtering, digital manipulation, and quantitative measurements. The client software is designed to run on standard personal and business computers and on monitors/screens that meet appropriate technical specification for image diagnosis. Tempus Pixel software is intended to be used as a support tool by trained healthcare professionals to aid in diagnosis. It is intended to provide image and related information that is interpreted by a trained professional to render findings and/or diagnosis, but it does not directly generate any diagnosis or potential findings.”
source quote (p.6)
“The device also facilitates several FDA-cleared third party inference models.”
source quote (p.8)
“Locked/Static”
source quote (p.8)
“Cybersecurity Testing: Cybersecurity activities were completed and associated risks have been appropriately mitigated.”
Validation studies (3)
Bench
n=120 other
endpoints: The 95th percentile deviation (absolute error) between the Tempus Pixel inline maps and scanner generated inline maps, as assessed across means from all 120 ROIs, must be within the range from -30ms to +30ms.; All measurements must be within 1.5 times this range (-45ms to +45ms).; The 95th percentile deviation (absolute error) between the Tempus Pixel inline maps and scanner generated inline maps, as assessed across means from all 120 ROIs, must be within the range from -3ms to +3ms.; All measurements must be within 1.5 times this range (-4.5ms to +4.5ms).
Bench
sample size not stated
endpoints: SW V&V activities were completed and all Unit Tests, Integration Tests, and System Tests met the acceptance criteria.
Reader study (MRMC)
n=3 other
endpoints: documented User Needs were satisfied; When a study with a parametric mapping raw data series (T1/T2) is opened, there will automatically be an inline map generated by Tempus located in the series list within the study.; When the user loads a parametric mapping raw data series into the viewer and opens the corresponding module, they will have the option to generate a new inline map.; When the user generates a new inline map, the inline map will populate within the series list and will have a distinct series description.; Users are able to quantify T1/T2 values from the Pixel generated inline map and verify these values against expected anatomical/ pathological findings.
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
Recall and MAUDE counts are product-code-level (reports aren't reliably attributable to one device). 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).