510(k) · Cleared
ClearedLipiscan Ivus Imaging System Model Nirs-MC7-70
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Infraredx, Inc. · OGZ Catheter, Intravascular, Plaque Morphology Evaluation
Cleared on Jun 30, 2010 as substantially equivalent to K072932 (Infraredx, Inc., 2008) and 2 other predicates after a 188-day review. Its family tree reaches back 6 generations to 1995.
- Decided
- Jun 30, 2010
- Review
- 188 days
- Class
- Class II
- Product code
- OGZ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 6 generations to K934139 (1995). 16 ancestors in all, the oldest K921750 (1992). No later device cites it as a predicate yet.
- Root · 6 generations backK934139 Tomtec Echo-ViewTomtec Tomographic Technologies GmbH · 1995
- 5 generations backK993398 Echo View, Easy View, Omni ViewTomtec Imaging Systems GmbH · 1999
- 4 generations backK022824 Echo-View 5.X, Easy-View 2.X, Omni View 2.X, Cardio-View 1.X, LV…Tomtec Imaging Systems GmbH · 2002
- 3 generations backK042188 Volcano Therapeutics, Inc. Volcano Ivus SystemVolcano Therapeutics, Inc. · 2004
- 2 generations backK051337 Eagle Eye Gold Ivus Imaging Catheter, Model 85900/859XX; Volcano…Volcano Corporation · 2005
- 1 generation backK072932 Infraredix Nir Imaging System, Gen. 1.0, Model MC-5Infraredx, Inc. · 2008
- This deviceK093993 Lipiscan Ivus Imaging System Model Nirs-MC7-70Infraredx, Inc. · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K934139 | Tomtec Echo-View | Tomtec Tomographic Technologies GmbH | 1995 | — |
| −5 | K993398 | Echo View, Easy View, Omni View | Tomtec Imaging Systems GmbH | 1999 | — |
| −4 | K022824 | Echo-View 5.X, Easy-View 2.X, Omni View 2.X, Cardio-View 1.X, LV Analysis 1.X… | Tomtec Imaging Systems GmbH | 2002 | — |
| −3 | K042188 | Volcano Therapeutics, Inc. Volcano Ivus System | Volcano Therapeutics, Inc. | 2004 | — |
| −2 | K051337 | Eagle Eye Gold Ivus Imaging Catheter, Model 85900/859XX; Volcano VH-Ivus… | Volcano Corporation | 2005 | — |
| −1 | K072932 | Infraredix Nir Imaging System, Gen. 1.0, Model MC-5 | Infraredx, Inc. | 2008 | — |
| 0 (this device) | K093993 | Lipiscan Ivus Imaging System Model Nirs-MC7-70 | Infraredx, Inc. | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1993 | 2 | 0 |
| 1998 | 1 | 0 |
| 2000 | 2 | 0 |
| 2003 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 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 OGZ? 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 OGZ device
- #1 K241576 Makoto Intravascular Imaging System™ (VC-MC10…score 9.2 · 2 generations · no Class I recall
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K072932 | Infraredix Nir Imaging System, Gen. 1.0, Model MC-5Summary page 1…fraReDx LiplScanTh IVUS Imaging System Device Common Name: Near lnfraredflVUS Imaging System Predicate Devices: lnfraReDx UpiScanWv IVUS Imaging System (K072932) Boston Scientific iLab Ultrasound Imaging System (K051679), Boston Scien… | 2008 |
| * | K051679 | Ilab Ultrasound Imaging SystemSummary page 1…ces: lnfraReDx UpiScanWv IVUS Imaging System (K072932) Boston Scientific iLab Ultrasound Imaging System (K051679), Boston Scientific Atlantis SR Pro Catheter (K050577) Device Description: The lnfraReDx Lipi… | 2005 |
| * | K050577 | Atlantis SR PRO2 Coronary Imaging Catheter, Model 39014Summary page 1…Boston Scientific iLab Ultrasound Imaging System (K051679), Boston Scientific Atlantis SR Pro Catheter (K050577) Device Description: The lnfraReDx LipiScan~m IVUS Imaging System is comprised of the cathete… | 2005 |
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 15 years and passes through 5 companies; a new generation was cleared every 2.7 years on median.
- 2 of the 16 ancestors have a recall of any class.
How does its category compare?
All OGZ devicesOGZ Catheter, Intravascular, Plaque Morphology Evaluation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · OGZ
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OGZ
Too few OGZ 510(k)s in any year since 2007 to give a median.
Recalls per year · OGZ
1in 2016
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OGZ
2in 2025
MAUDE reports naming product code OGZ, 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 | 1 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 2 | — | 0 | 3 |
| 2014 | 2 | — | 0 | 2 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 1 | 0 |
| 2017 | 1 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 4 |
| 2019 | 1 | — | 0 | 2 |
| 2020 | 0 | — | 0 | 4 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 3 |
| 2025 | 1 | — | 0 | 2 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
1. The LipiScan TM IVUS Imaging System is intended for the near-infrared examination of coronary arteries in patients undergoing invasive coronary angiography.
a. The System is intended for the detection of lipid-core-containing plaques of interest.
b. The System is intended for the assessment of coronary artery lipid core burden.
2. The System is intended for ultrasound examination of coronary intravascular pathology.
a. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal coronary interventional procedures.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K093993 · printed Nov 6, 2026
Cite this page
510(k) Report. “K093993: Lipiscan Ivus Imaging System Model Nirs-MC7-70.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K093993
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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