510(k) · Cleared
ClearedTempus Pixel
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Arterys, Inc. · QIH Automated Radiological Image Processing Software
Cleared on Sep 3, 2025 as substantially equivalent to K203744 (Arterys, Inc., 2022) after a 22-day review. Its family tree reaches back 14 generations to 1991.
- Decided
- Sep 3, 2025
- Review
- 22 days
- Class
- Class II
- Product code
- QIH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 14 generations to K913770 (1991). 119 ancestors in all, the oldest K871859 (1987). No later device cites it as a predicate yet.
- Root · 14 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 10 generations between
- 3 generations backK182034 Arterys MICAArterys, Inc. · 2018
- 2 generations backK192437 Arterys MICAArterys, Inc. · 2020
- 1 generation backK203744 Arterys MICAArterys, Inc. · 2022
- This deviceK252539 Tempus PixelArterys, Inc. · 2025
Show all 14 generations
- Root · 14 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 13 generations backK963345 Advantage Windows Tissue Volume OptionGE Medical Systems · 1996
- 12 generations backK013381 Advanced Lung Analysis-1General Electric Co. · 2001
- 11 generations backK022013 Lungcare CT Software PackageSiemens Medical Solutions USA, Inc. · 2002
- 10 generations backK033374 Lungcare CT Software Package with Extended FunctionalitySiemens AG Medical Solutions · 2003
- 9 generations backK041484 UndecidedSiemens Medical Solutions USA, Inc. · 2004
- 8 generations backK053301 Cedara I-Response Cedara Pet/CTCedara Software Corp. · 2006
- 7 generations backK071950 Syngo TruedSiemens Medical Solutions USA, Inc. · 2007
- 6 generations backK091373 Syngo TruedSiemens Medical Solutions USA, Inc. · 2009
- 5 generations backK101749 Syngo Trued SoftwareSiemens Medical Solutions · 2010
- 4 generations backK173542 Arterys Oncology DLArterys, Inc. · 2018
- 3 generations backK182034 Arterys MICAArterys, Inc. · 2018
- 2 generations backK192437 Arterys MICAArterys, Inc. · 2020
- 1 generation backK203744 Arterys MICAArterys, Inc. · 2022
- This deviceK252539 Tempus PixelArterys, Inc. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K913770 | Advantage V.S. CT/MR Rad Diagnostic Workstation | General Electric Co. | 1991 | — |
| −13 | K963345 | Advantage Windows Tissue Volume Option | GE Medical Systems | 1996 | — |
| −12 | K013381 | Advanced Lung Analysis-1 | General Electric Co. | 2001 | — |
| −11 | K022013 | Lungcare CT Software Package | Siemens Medical Solutions USA, Inc. | 2002 | — |
| −10 | K033374 | Lungcare CT Software Package with Extended Functionality | Siemens AG Medical Solutions | 2003 | — |
| −9 | K041484 | Undecided | Siemens Medical Solutions USA, Inc. | 2004 | — |
| −8 | K053301 | Cedara I-Response Cedara Pet/CT | Cedara Software Corp. | 2006 | — |
| −7 | K071950 | Syngo Trued | Siemens Medical Solutions USA, Inc. | 2007 | — |
| −6 | K091373 | Syngo Trued | Siemens Medical Solutions USA, Inc. | 2009 | — |
| −5 | K101749 | Syngo Trued Software | Siemens Medical Solutions | 2010 | — |
| −4 | K173542 | Arterys Oncology DL | Arterys, Inc. | 2018 | — |
| −3 | K182034 | Arterys MICA | Arterys, Inc. | 2018 | — |
| −2 | K192437 | Arterys MICA | Arterys, Inc. | 2020 | — |
| −1 | K203744 | Arterys MICA | Arterys, Inc. | 2022 | — |
| 0 (this device) | K252539 | Tempus Pixel | Arterys, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 5 | 0 |
| 1992 | 2 | 0 |
| 1993 | 4 | 0 |
| 1994 | 4 | 0 |
| 1995 | 4 | 0 |
| 1996 | 6 | 0 |
| 1997 | 4 | 0 |
| 1998 | 7 | 0 |
| 1999 | 4 | 0 |
| 2000 | 8 | 0 |
| 2001 | 10 | 0 |
| 2002 | 10 | 0 |
| 2003 | 4 | 0 |
| 2004 | 11 | 0 |
| 2005 | 4 | 0 |
| 2006 | 2 | 0 |
| 2007 | 3 | 0 |
| 2008 | 1 | 0 |
| 2011 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in QIH? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new QIH device
- #1 K213998 cvi42 Auto Imaging Software Applicationscore 23.5 · 7 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K203744 | Arterys MICASummary page 5…21 CFR 892.2050 Product Code: QIH, LLZ Predicate Device: Arterys MICA Submission Number: K203744 Product Code: QIH, LLZ Indications For Use Tempus Pixel software is a medical diagnostic application… | 2022 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 34 years and passes through 7 companies; a new generation was cleared every 1.5 years on median.
- 25 of the 119 ancestors have a recall of any class.
How does its category compare?
All QIH devicesQIH Automated Radiological Image Processing Software: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · QIH
94in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QIH
150in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · QIH
1so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · QIH
4in 2025
MAUDE reports naming product code QIH, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 2 | — | 0 | 0 |
| 2020 | 11 | 145 | 0 | 0 |
| 2021 | 19 | 125 | 0 | 0 |
| 2022 | 25 | 134 | 0 | 0 |
| 2023 | 45 | 151 | 0 | 0 |
| 2024 | 64 | 141 | 0 | 2 |
| 2025 | 94 | 150 | 0 | 4 |
| 2026 | 78 | 130 | 1 | — |
What is it indicated for?
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.…
Read the full statement (229 words)
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 includes an optional Pixel Cardio module which is used to analyze the heart and its major vessels using multi-slice, multi-phase, and velocity-encoded cardiovascular magnetic resonance (MR) images. It provides clinically relevant and reproducible, quantitative data, and has been tested and validated on MR images acquired from both 1.5T and 3.0T MR Scanners.
Tempus Pixel includes an optional Pixel Therapy Response Evaluation module which provides analytical tools to help the user assess and document changes in morphological activity at diagnostic and therapy follow-up examinations. It is a tool used to support the oncological workflow by helping the user confirm the absence or presence of lesions, including evaluation, quantification, follow-up, and documentation of any such lesions.
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K252539 · printed Nov 6, 2026
Cite this page
510(k) Report. “K252539: Tempus Pixel.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K252539
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026