510(k) · Cleared
ClearedCORRIDOR4DM
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Invia · KPS System, Tomography, Computed, Emission
Cleared on May 13, 2008 as substantially equivalent to K001026 (The Reagents of the University of Michigan, 2000) and 1 other predicate after a 74-day review. Its family tree reaches back 3 generations to 1995. 15 later devices descend from it.
- Decided
- May 13, 2008
- Review
- 74 days
- Class
- Class II
- Product code
- KPS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K945428 (1995). 5 ancestors in all. 15 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK945428 Scribe (TM) Diagnostic Imaging WorkstationMulti-Dimensional Imaging, Inc. · 1995
- 2 generations backK960911 Netra Workstation System & Netra MD SoftwareScimage, Inc. · 1996
- 1 generation backK990426 Calcium ScoringSiemens Medical Solutions USA, Inc. · 1999
- This deviceK080575 CORRIDOR4DMInvia · 2008
- Descendant · cites it directly · 12 of its ownK101279 CORRIDOR4DM V2010 Model: V2010Invia · 2010
- Descendant · 2 generations on · 9 of its ownK113754 CFR QuantUniversity of Texas Medical School AT Houston · 2012
- Descendant · 3 generations on · 6 of its ownK143664 HeartSeeUniversity of Texas Medical School AT Houston · 2015
- Descendant · 4 generations on · 5 of its ownK171303 Added Screen Displays For FDA Cleared HeartSee Cardiac P.E.T…University of Texas Medical School AT Houston, Texas · 2017
- Descendant · 2 generations on · 3 of its ownK123646 Emory Cardiac Toolbox 4.0Syntermed, Inc. · 2013
Showing 5 of 15 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 15 · See all- K101279CORRIDOR4DM V2010 Model: V2010Invia · 2010 · cites it directly12descendants
- K113754CFR QuantUniversity of Texas Medical School AT Houston · 2012 · 2 generations on9descendants
- K143664HeartSeeUniversity of Texas Medical School AT Houston · 2015 · 3 generations on6descendants
- K171303Added Screen Displays For FDA Cleared HeartSee Cardiac P.E.T Processing Software K143664University of Texas Medical School AT Houston, Texas · 2017 · 4 generations on5descendants
- K123646Emory Cardiac Toolbox 4.0Syntermed, Inc. · 2013 · 2 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K945428 | Scribe (TM) Diagnostic Imaging Workstation | Multi-Dimensional Imaging, Inc. | 1995 | — |
| −2 | K960911 | Netra Workstation System & Netra MD Software | Scimage, Inc. | 1996 | — |
| −1 | K990426 | Calcium Scoring | Siemens Medical Solutions USA, Inc. | 1999 | — |
| 0 (this device) | K080575 | CORRIDOR4DM | Invia | 2008 | — |
| +1 | K101279 | CORRIDOR4DM V2010 Model: V2010 | Invia | 2010 | — |
| +2 | K113754 | CFR Quant | University of Texas Medical School AT Houston | 2012 | — |
| +3 | K143664 | HeartSee | University of Texas Medical School AT Houston | 2015 | — |
| +4 | K171303 | Added Screen Displays For FDA Cleared HeartSee Cardiac P.E.T Processing… | University of Texas Medical School AT Houston, Texas | 2017 | — |
| +2 | K123646 | Emory Cardiac Toolbox 4.0 | Syntermed, Inc. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 3 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 2 | 0 |
| 2025 | 1 | 0 |
| 2026 | 1 | 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 KPS? 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 KPS device
- #1 K253564 uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI…score 18.6 · 17 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K001026 | 3D-Mspect | 2000 |
| * | K990426 | Calcium ScoringSummary page 1…750 CLASS II Product Code KPS, JAK C) Predicate: Reagents of the University of Michigan 3D-MSPECT system (KOO 1026) Siemens, Calcium Scoring Software Package (K990426) D) Device Description: Corridor4DM is a comprehensive cardiac emission computed tomographic (ECT) application designed to revi… | 1999 |
What descends from it? (15)
See all 152 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
How does its category compare?
All KPS devicesKPS System, Tomography, Computed, Emission: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · KPS
12in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KPS
65in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KPS
16in 2025
Class I (17 since 2007) Class II/III not classified
Adverse event reports per year · KPS
36in 2025
MAUDE reports naming product code KPS, 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 | 8 | 38 | 22 | 38 |
| 2008 | 17 | 25 | 16 | 11 |
| 2009 | 9 | 42 | 14 | 15 |
| 2010 | 3 | 91 | 4 | 44 |
| 2011 | 7 | 28 | 34 | 56 |
| 2012 | 6 | 94 | 13 | 34 |
| 2013 | 11 | 84 | 13 | 240 |
| 2014 | 11 | 92 | 18 | 33 |
| 2015 | 3 | 112 | 5 | 24 |
| 2016 | 11 | 65 | 16 | 10 |
| 2017 | 11 | 104 | 11 | 31 |
| 2018 | 13 | 59 | 12 (3) | 26 |
| 2019 | 3 | 60 | 5 (5) | 105 |
| 2020 | 12 | 72 | 8 | 22 |
| 2021 | 15 | 66 | 4 | 10 |
| 2022 | 5 | 60 | 8 (6) | 15 |
| 2023 | 12 | 63 | 6 (3) | 22 |
| 2024 | 11 | 59 | 15 | 23 |
| 2025 | 12 | 65 | 16 | 36 |
| 2026 | 6 | 67 | 6 | — |
What is it indicated for?
Invia's Corridor4DM application is intended to provide processing, quantification, and multidimensional review of reconstructed cardiac emission tomographic studies (SPECT and PET). Cardiac CT interpretation and calcium quantification are optional features that are integrated into Corridor4DM (SPECT-CT and PET-CT). The calcium-scoring package is a non-invasive diagnostic tool that can be used to evaluate the calcified plaques in the coronary arteries, a…
Read the full statement (130 words)
Invia's Corridor4DM application is intended to provide processing, quantification, and multidimensional review of reconstructed cardiac emission tomographic studies (SPECT and PET). Cardiac CT interpretation and calcium quantification are optional features that are integrated into Corridor4DM (SPECT-CT and PET-CT). The calcium-scoring package is a non-invasive diagnostic tool that can be used to evaluate the calcified plaques in the coronary arteries, a risk factor for coronary artery disease. Calcium scoring may be used to monitor the progression or regression overtime of the amount or volume of calcium in the coronary arteries, which may be related to the prognosis of a cardiac attack. Coregistration or fusion of volumetric data (ECT and/or CT) is provided as a quality control for the identification of structures where correlative spatial information is necessary for a diagnostic interpretation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080575 · printed Nov 6, 2026
Cite this page
510(k) Report. “K080575: CORRIDOR4DM.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K080575
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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