510(k) · Cleared
ClearedCORRIDOR4DM V2010 Model: V2010
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Invia · LLZ System, Image Processing, Radiological
Cleared on Aug 4, 2010 as substantially equivalent to K080575 (Invia, 2008) and 4 other predicates after a 90-day review. Its family tree reaches back 6 generations to 1991. 1 of the 43 devices in its family, counting itself, has a Class I recall. 12 later devices descend from it.
- Decided
- Aug 4, 2010
- Review
- 90 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 6 generations to K913770 (1991). 30 ancestors in all, the oldest K892358 (1989). 12 later devices descend from it, 4 citing it directly. 1 of the 43 devices in this family, counting this one, has a Class I recall.
- Root · 6 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 5 generations backK963345 Advantage Windows Tissue Volume OptionGE Medical Systems · 1996
- 4 generations backK013381 Advanced Lung Analysis-1General Electric Co. · 2001
- 3 generations backK022013 Lungcare CT Software PackageSiemens Medical Solutions USA, Inc. · 2002
- 2 generations backK063762 Syngo Circulation Software Package with Extended FunctionalitySiemens AG Medical Solutions · 2007
- 1 generation backK083327 Syngocirculation Dynamicpet, Version 1.0Siemens Medical Solutions USA, Inc. · 2009
- This deviceK101279 CORRIDOR4DM V2010 Model: V2010Invia · 2010
- Descendant · cites it directly · 9 of its ownK113754 CFR QuantUniversity of Texas Medical School AT Houston · 2012
- Descendant · 2 generations on · 6 of its ownK143664 HeartSeeUniversity of Texas Medical School AT Houston · 2015
- Descendant · 3 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 · cites it directly · 3 of its ownK123646 Emory Cardiac Toolbox 4.0Syntermed, Inc. · 2013
- Descendant · 4 generations on · 2 of its ownK202679 Optional Screen Display for HeartSee Cardiac P.E.T. Processing…Mcgovern Medical School · 2021
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K991841 Hawkeye Option for Dual-Head Variable Angle…2 generations back · 1999
Most influential descendants
Showing 5 of 12 · See all- K113754CFR QuantUniversity of Texas Medical School AT Houston · 2012 · cites it directly9descendants
- K143664HeartSeeUniversity of Texas Medical School AT Houston · 2015 · 2 generations on6descendants
- K171303Added Screen Displays For FDA Cleared HeartSee Cardiac P.E.T Processing Software K143664University of Texas Medical School AT Houston, Texas · 2017 · 3 generations on5descendants
- K123646Emory Cardiac Toolbox 4.0Syntermed, Inc. · 2013 · cites it directly3descendants
- K202679Optional Screen Display for HeartSee Cardiac P.E.T. Processing Software - HeartSee…Mcgovern Medical School · 2021 · 4 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K913770 | Advantage V.S. CT/MR Rad Diagnostic Workstation | General Electric Co. | 1991 | — |
| −5 | K963345 | Advantage Windows Tissue Volume Option | GE Medical Systems | 1996 | — |
| −4 | K013381 | Advanced Lung Analysis-1 | General Electric Co. | 2001 | — |
| −3 | K022013 | Lungcare CT Software Package | Siemens Medical Solutions USA, Inc. | 2002 | — |
| −2 | K063762 | Syngo Circulation Software Package with Extended Functionality | Siemens AG Medical Solutions | 2007 | — |
| −1 | K083327 | Syngocirculation Dynamicpet, Version 1.0 | Siemens Medical Solutions USA, Inc. | 2009 | — |
| 0 (this device) | K101279 | CORRIDOR4DM V2010 Model: V2010 | Invia | 2010 | — |
| +1 | K113754 | CFR Quant | University of Texas Medical School AT Houston | 2012 | — |
| +2 | K143664 | HeartSee | University of Texas Medical School AT Houston | 2015 | — |
| +3 | K171303 | Added Screen Displays For FDA Cleared HeartSee Cardiac P.E.T Processing… | University of Texas Medical School AT Houston, Texas | 2017 | — |
| +1 | K123646 | Emory Cardiac Toolbox 4.0 | Syntermed, Inc. | 2013 | — |
| +4 | K202679 | Optional Screen Display for HeartSee Cardiac P.E.T. Processing Software -… | Mcgovern Medical School | 2021 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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.
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 LLZ device
- #1 K230955 syngo Application Softwarescore 21.5 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (5)
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 |
|---|---|---|---|
| * | K080575 | CORRIDOR4DMSummary page 1…device(s): Device Manufacturer 5 10(k) Number Corridor4DM INVIA, LLC K080575 syngoCirculation DynamicPfll Siemens K083327 Syngo® Circulation Siemens… | 2008 |
| * | K083327 | Syngocirculation Dynamicpet, Version 1.0Summary page 1…5 10(k) Number Corridor4DM INVIA, LLC K080575 syngoCirculation DynamicPfll Siemens K083327 Syngo® Circulation Siemens K063762 E.CAM Siemens… | 2009 |
| * | K063762 | Syngo Circulation Software Package with Extended FunctionalitySummary page 1…K080575 syngoCirculation DynamicPfll Siemens K083327 Syngo® Circulation Siemens K063762 E.CAM Siemens K023190 Odyssey LX Model Philips… | 2007 |
| * | K023190 | E.Cam Computer / E.Soft WorkstationSummary page 1…K083327 Syngo® Circulation Siemens K063762 E.CAM Siemens K023190 Odyssey LX Model Philips Medical K003437 D) Device Description: Corridor4DM v201… | 2002 |
| * | K003437 | Odyssey LX, Model 211320Summary page 1…K063762 E.CAM Siemens K023190 Odyssey LX Model Philips Medical K003437 D) Device Description: Corridor4DM v201 0 is a comprehensive application designed to process, review, and quantitat… | 2001 |
What descends from it? (12)
See all 124 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 · 2 generations back · ◆ in the 1999 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 19 years and passes through 5 companies; a new generation was cleared every 4.5 years on median.
- 8 of the 30 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K113754 (University of Texas Medical School AT Houston, 2012) has gone furthest, with 9 descendants of its own.
- 1 other device also cites its predicate K080575.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · LLZ
58in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LLZ
173in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LLZ
11in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LLZ
116in 2025
MAUDE reports naming product code LLZ, 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 | 76 | 36 | 20 | 152 |
| 2008 | 94 | 52 | 32 | 154 |
| 2009 | 70 | 62 | 21 | 145 |
| 2010 | 51 | 98 | 17 | 145 |
| 2011 | 106 | 79 | 30 | 454 |
| 2012 | 82 | 87 | 12 | 266 |
| 2013 | 95 | 84 | 64 | 1,130 |
| 2014 | 78 | 89 | 6 | 15,631 |
| 2015 | 64 | 90 | 16 | 211 |
| 2016 | 82 | 90 | 12 | 290 |
| 2017 | 78 | 107 | 5 | 104 |
| 2018 | 104 | 105 | 7 | 72 |
| 2019 | 74 | 107 | 2 | 88 |
| 2020 | 81 | 115 | 6 | 82 |
| 2021 | 83 | 116 | 3 | 70 |
| 2022 | 65 | 137 | 4 | 28 |
| 2023 | 87 | 157 | 8 | 26 |
| 2024 | 62 | 131 | 6 | 42 |
| 2025 | 58 | 173 | 11 | 116 |
| 2026 | 45 | 110 | 14 | — |
What is it indicated for?
INVIA's Cotridor4DM v201 0Oapplication is intended to provide processing quantification, and multidimensional review of the biodistribution of radionuclides in the body using planar and tomographic images. The application performs quantitative measurements of tracer uptake over time to aid in the interpretation of myocardial perfusion emission tomographic images. Cardiac CT interpretation and calcium quantification are optional features that are…
Read the full statement (123 words)
INVIA's Cotridor4DM v201 0Oapplication is intended to provide processing quantification, and
multidimensional review of the biodistribution of radionuclides in the body using planar and
tomographic images. The application performs quantitative measurements of tracer uptake over
time to aid in the interpretation of myocardial perfusion emission tomographic images. 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. Co-registration or fusion of volumetric data (ECT and/or CT)
is providel 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/K101279 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101279: CORRIDOR4DM V2010 Model: V2010.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101279
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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