Tempus Pixel

Tempus Pixel is cloud-hosted medical imaging software that displays, processes, stores, and transfers DICOM and non-DICOM medical data. It provides image storage, filtering, digital manipulation, and quantitative measurement capabilities. Optional modules include Pixel Cardio for analyzing heart and vessels using multi-slice, multi-phase cardiovascular MR images, and Pixel Therapy Response Evaluation for assessing morphological changes in oncology follow-ups. The software is intended as a support tool for trained healthcare professionals to aid diagnosis, not to directly generate diagnoses.

Tempus Pixel has substantially identical technological characteristics to the predicate Arterys MICA device, including identical intended use, patient population, image types (CT, MR, ultrasound, x-ray, mammography), and core features (2D/3D display, measurement tools, reporting, cardiac views, and visualization workflows). The primary modification is addition of full device-generated T1 and T2 inline map functionality, whereas the predicate was limited to user-defined regions of interest (ROIs). This enhanced mapping feature uses the same underlying process and calculations as the predicate's ROI quantification.

Not stated in this summary.

The device meets substantial equivalence because it maintains identical intended use, indications, patient population, and regulatory classification (Class II, Rx) as the predicate. Non-clinical validation demonstrates that the new T1/T2 inline mapping feature generates outputs within clinically acceptable tolerances compared to FDA-cleared MR scanners (T1 within ±30 ms, T2 within ±3 ms at 95th percentile). Software verification and human factors testing both passed without deviations. The minor technological difference—automated inline map generation versus manual ROI quantification—does not raise different safety or effectiveness questions because it employs identical underlying calculations and the clinician retains ultimate diagnostic responsibility.