510(k) · Cleared
Cleared4DM
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Invia, LLC · QIH Automated Radiological Image Processing Software
Cleared on Sep 10, 2026 as substantially equivalent to K101279 (Invia, 2010) after a 177-day review. Its family tree reaches back 7 generations to 1991. 1 of the 32 devices in its family, counting itself, has a Class I recall.
- Decided
- Sep 10, 2026
- Review
- 177 days
- Class
- Class II
- Product code
- QIH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K913770 (1991). 31 ancestors in all, the oldest K892358 (1989). No later device cites it as a predicate yet. 1 of the 32 devices in this family, counting this one, has a Class I recall.
- Root · 7 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 6 generations backK963345 Advantage Windows Tissue Volume OptionGE Medical Systems · 1996
- 5 generations backK013381 Advanced Lung Analysis-1General Electric Co. · 2001
- 4 generations backK022013 Lungcare CT Software PackageSiemens Medical Solutions USA, Inc. · 2002
- 3 generations backK063762 Syngo Circulation Software Package with Extended FunctionalitySiemens AG Medical Solutions · 2007
- 2 generations backK083327 Syngocirculation Dynamicpet, Version 1.0Siemens Medical Solutions USA, Inc. · 2009
- 1 generation backK101279 CORRIDOR4DM V2010 Model: V2010Invia · 2010
- This deviceK260879 4DMInvia, LLC · 2026
Class I recalls in this family
- K991841 Hawkeye Option for Dual-Head Variable Angle…3 generations back · 1999
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K913770 | Advantage V.S. CT/MR Rad Diagnostic Workstation | General Electric Co. | 1991 | — |
| −6 | K963345 | Advantage Windows Tissue Volume Option | GE Medical Systems | 1996 | — |
| −5 | K013381 | Advanced Lung Analysis-1 | General Electric Co. | 2001 | — |
| −4 | K022013 | Lungcare CT Software Package | Siemens Medical Solutions USA, Inc. | 2002 | — |
| −3 | K063762 | Syngo Circulation Software Package with Extended Functionality | Siemens AG Medical Solutions | 2007 | — |
| −2 | K083327 | Syngocirculation Dynamicpet, Version 1.0 | Siemens Medical Solutions USA, Inc. | 2009 | — |
| −1 | K101279 | CORRIDOR4DM V2010 Model: V2010 | Invia | 2010 | — |
| 0 (this device) | K260879 | 4DM | Invia, LLC | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1991 | 1 | 0 |
| 1995 | 3 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 3 | 1 |
| 2000 | 4 | 0 |
| 2001 | 3 | 0 |
| 2002 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2008 | 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.
1 device in this family has a Class I recall. 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 23.6 · 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.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K991841Hawkeye Option for Dual-Head Variable Angle Gamma CameraGe Medical Systems F.I. Haifa · 1999 · 3 generations back · ◆ in the 1999 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 35 years and passes through 6 companies; a new generation was cleared every 4.5 years on median.
- 8 of the 31 ancestors have a recall of any class; 1 has a Class I recall.
- 3 other devices also cite its predicate K101279.
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. 2026, 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?
4DM is a software application used by medical professionals to analyze and report nuclear medicine, PET, CT, MR and hybrid patient studies to support their assessment of a patient's cardiac health. 4DM provides tools to process, review, quantify, and display static, whole body, dynamic, gated planar, standard ungated ECT images, ECG gated ECT images, and dynamic ECT images. 4DM software performs quantification and enables: • Assessment of Cardiac…
Read the full statement (369 words)
4DM is a software application used by medical professionals to analyze and report nuclear medicine, PET, CT, MR and hybrid patient studies to support their assessment of a patient's cardiac health.
4DM provides tools to process, review, quantify, and display static, whole body, dynamic, gated planar, standard ungated ECT images, ECG gated ECT images, and dynamic ECT images.
4DM software performs quantification and enables:
• Assessment of Cardiac Function with Nuclear Myocardial Perfusion Imaging
o Quantify ventricular function (e.g. volumes, ejection fraction , diastolic) from radiotracer appropriate (e.g. perfusion, metabolism) gated ECT volumetric images.
o Quantify regional ventricular function (e.g. wall motion, thickening, contractility) from radiotracer appropriate (e.g. perfusion, metabolism) gated ECT volumetric images.
• Assessment of Cardiac Function with Nuclear Gated Blood Pool Imaging
o Quantify ventricular volumes and the ejection fraction (EF) from gated ECT blood pool images.
o Quantify ejection fraction (EF) from planar gated blood pool images.
• Assessment of Myocardial Perfusion with Nuclear Myocardial Perfusion Imaging
o Quantify regional relative myocardial perfusion with comparison to normal limits for interpretation of perfusion abnormalities by the Clinician.
o Provide semi-quantitative segmental myocardial perfusion scoring using standard segmental overlay(s).
o Quantify transient ischemic dilation from stress-rest myocardial perfusion images.
• Assessment of Myocardial Blood Flow with Nuclear Cardiology Imaging
o Quantify and display myocardial blood flow and flow reserve from SPECT or PET dynamic sequences.
• Assessment of Myocardial Viability with Nuclear Cardiology Imaging
o Quantify regional perfusion and metabolic radiotracer uptake for the interpretation of viable myocardium by the Clinician.
• Assessment of Inflammation and Infection with Nuclear Cardiology Imaging
o Quantify regional radiotracer uptake for the review and interpretation of the presence of inflammation and infection in the heart and body by the Clinician.
• Assessment of Cardiac Coronary Calcium with CT Imaging
o Quantify the presence of calcium in the coronary vessels for review and interpretation by the Clinician.
• SPECT Image Reconstruction
o Motion correction of SPECT tomographic projection images for patient or organ motion.
o Image reconstruction of SPECT tomographic projection images with post reconstruction filtering and reorientation.
4DM shall be used by qualified medical professionals. It does not provide diagnoses or therapeutic recommendations but is instead a visual and quantitative aid.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K260879 · printed Nov 4, 2026
Cite this page
510(k) Report. “K260879: 4DM.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K260879
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026