510(k) · Cleared
Recalled · Class III · 2022IntraSight Mobile
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Volcano Corporation · IYO System, Imaging, Pulsed Echo, Ultrasonic
Cleared on Jan 19, 2021 as substantially equivalent to K190078 (Volcano Corporation, 2019) after a 29-day review. Its family tree reaches back 14 generations to 1995. It has been recalled once.
- Decided
- Jan 19, 2021
- Review
- 29 days
- Class
- Class II
- Product code
- IYO
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 14 generations to K934139 (1995). 52 ancestors in all, the oldest K823434 (1982). No later device cites it as a predicate yet.
- Root · 14 generations backK934139 Tomtec Echo-ViewTomtec Tomographic Technologies GmbH · 1995
- 10 generations between
- 3 generations backK170133 FFR V2.5Philips Volcano · 2017 · Recalled
- 2 generations backK173860 s5 Intravascular Ultrasound Imaging and Pressure Systems, s5i…Volcano Corporation · 2018
- 1 generation backK190078 IntraSightVolcano Corporation · 2019
- This deviceK203719 IntraSight MobileVolcano Corporation · 2021
Show all 14 generations
- Root · 14 generations backK934139 Tomtec Echo-ViewTomtec Tomographic Technologies GmbH · 1995
- 13 generations backK993398 Echo View, Easy View, Omni ViewTomtec Imaging Systems GmbH · 1999
- 12 generations backK022824 Echo-View 5.X, Easy-View 2.X, Omni View 2.X, Cardio-View 1.X, LV…Tomtec Imaging Systems GmbH · 2002
- 11 generations backK042188 Volcano Therapeutics, Inc. Volcano Ivus SystemVolcano Therapeutics, Inc. · 2004
- 10 generations backK051337 Eagle Eye Gold Ivus Imaging Catheter, Model 85900/859XX; Volcano…Volcano Corporation · 2005
- 9 generations backK071554 Volcano S5/S5I Intravascular Imaging and Pressure SystemVolcano Corporation · 2008 · Recalled
- 8 generations backK082229 S5/S5I Series Intravascular Imaging and Pressure System, Combomap…Volcano Corporation · 2008 · Recalled
- 7 generations backK111706 Volcano S5IINTRAVASCULAR Imaging and Pressure SystemVolcano Corporation · 2011 · Recalled
- 6 generations backK123898 Volcano S5/S5I Intravascular Ultrasound Imaging and Pressure SystemVolcano Corporation · 2013 · Recalled
- 5 generations backK133323 Volcano Ifr ModalityVolcano Corporation · 2014
- 4 generations backK150441 Volcano iFR Modality, iFR Scout featureVolcano Corporation · 2015
- 3 generations backK170133 FFR V2.5Philips Volcano · 2017 · Recalled
- 2 generations backK173860 s5 Intravascular Ultrasound Imaging and Pressure Systems, s5i…Volcano Corporation · 2018
- 1 generation backK190078 IntraSightVolcano Corporation · 2019
- This deviceK203719 IntraSight MobileVolcano Corporation · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K934139 | Tomtec Echo-View | Tomtec Tomographic Technologies GmbH | 1995 | — |
| −13 | K993398 | Echo View, Easy View, Omni View | Tomtec Imaging Systems GmbH | 1999 | — |
| −12 | 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 | — |
| −11 | K042188 | Volcano Therapeutics, Inc. Volcano Ivus System | Volcano Therapeutics, Inc. | 2004 | — |
| −10 | K051337 | Eagle Eye Gold Ivus Imaging Catheter, Model 85900/859XX; Volcano VH-Ivus… | Volcano Corporation | 2005 | — |
| −9 | K071554 | Volcano S5/S5I Intravascular Imaging and Pressure System | Volcano Corporation | 2008 | 2 |
| −8 | K082229 | S5/S5I Series Intravascular Imaging and Pressure System, Combomap Pressure and… | Volcano Corporation | 2008 | 3 |
| −7 | K111706 | Volcano S5IINTRAVASCULAR Imaging and Pressure System | Volcano Corporation | 2011 | 1 |
| −6 | K123898 | Volcano S5/S5I Intravascular Ultrasound Imaging and Pressure System | Volcano Corporation | 2013 | 10 |
| −5 | K133323 | Volcano Ifr Modality | Volcano Corporation | 2014 | — |
| −4 | K150441 | Volcano iFR Modality, iFR Scout feature | Volcano Corporation | 2015 | — |
| −3 | K170133 | FFR V2.5 | Philips Volcano | 2017 | 1 |
| −2 | K173860 | s5 Intravascular Ultrasound Imaging and Pressure Systems, s5i Intravascular… | Volcano Corporation | 2018 | — |
| −1 | K190078 | IntraSight | Volcano Corporation | 2019 | — |
| 0 (this device) | K203719 | IntraSight Mobile | Volcano Corporation | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 1 | 0 |
| 1986 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 5 | 0 |
| 1993 | 3 | 0 |
| 1994 | 3 | 0 |
| 1995 | 2 | 0 |
| 1996 | 3 | 0 |
| 1997 | 3 | 0 |
| 1998 | 3 | 0 |
| 2000 | 2 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 2 | 0 |
| 2005 | 3 | 0 |
| 2006 | 1 | 0 |
| 2007 | 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 IYO? 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 IYO device
- #1 K243937 Accuro 3Sscore 20.5 · 18 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 |
|---|---|---|---|
| * | K190078 | IntraSightSummary page 4…21 CFR Part 870.1110 DSK: 870.1110 Blood Pressure Computer PREDICATE DEVICE: IntraSight K190078 DEVICE DESCRIPTION: The IntraSight Mobile System provides qualitative and quantitative evaluation of vascular morpholo… | 2019 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 24, 2022 | Class III | Z-0901-2022 | Error in labeling | Multi-Modality Touch Screen Modules (MM-TSM), which are bedside/secondary control units, used as part of Mobile IVUS systems, are missing the following labeling information: Unique Device Identifier, Legal Manufacturer Information, Part… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 26 years and passes through 5 companies; a new generation was cleared every 1.9 years on median.
- 7 of the 52 ancestors have a recall of any class.
- 1 other device also cites its predicate K190078.
How does its category compare?
All IYO devicesIYO System, Imaging, Pulsed Echo, Ultrasonic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · IYO
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IYO
171in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IYO
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IYO
485in 2025
MAUDE reports naming product code IYO, 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 | 20 | 17 | 4 | 39 |
| 2008 | 14 | 36 | 5 | 20 |
| 2009 | 13 | 79 | 9 | 27 |
| 2010 | 15 | 113 | 8 | 20 |
| 2011 | 11 | 69 | 0 | 58 |
| 2012 | 15 | 68 | 2 | 78 |
| 2013 | 17 | 50 | 3 | 436 |
| 2014 | 14 | 63 | 2 | 304 |
| 2015 | 19 | 46 | 1 | 268 |
| 2016 | 10 | 36 | 0 | 254 |
| 2017 | 19 | 72 | 0 | 238 |
| 2018 | 14 | 56 | 1 | 368 |
| 2019 | 13 | 59 | 1 | 537 |
| 2020 | 11 | 57 | 0 | 498 |
| 2021 | 15 | 64 | 11 | 617 |
| 2022 | 5 | 190 | 1 | 511 |
| 2023 | 11 | 177 | 0 | 527 |
| 2024 | 10 | 220 | 0 | 640 |
| 2025 | 7 | 171 | 0 | 485 |
| 2026 | 10 | 139 | 1 | — |
What is it indicated for?
The IntraSight System is used for the qualitative and quantitative evaluation of vascular morphology in the coronary arteries and vessels of the peripheral vasculature. It is also indicated as an adjunct to conventional angiographic procedures to provide an image of vessel lumen and wall structures. ChromaFlo@ is indicated for qualitative blood flow information from peripheral and coronary vasculature; flow information can be an adjunct to other methods…
Read the full statement (265 words)
The IntraSight System is used for the qualitative and quantitative evaluation of vascular morphology in the coronary arteries and vessels of the peripheral vasculature. It is also indicated as an adjunct to conventional angiographic procedures to provide an image of vessel lumen and wall structures.
ChromaFlo@ is indicated for qualitative blood flow information from peripheral and coronary vasculature; flow information can be an adjunct to other methods of estimating blood flow and blood perfusion.
The pressure feature is intended for use in all blood vessels, including coronary and peripheral arteries, to measure intravascular blood pressure during diagnostic angiography and/or interventional procedures.
Rotational 45MHz feature is intended for the qualitative and quantitative evaluation of vascular morphology in the coronary arteries and vasculature as an adjunct to conventional angiographic procedures to provide an image of the vessel lumen and the wall structures. The Pullback feature of the PIMr withdraws the imaging core within the protective sheath for a maximum of 15 cm.
The FFR Modality is indicated in all blood vessels, including coronary and peripheral arteries, to measure intravascular blood pressure during diagnostic angiography and/or interventional procedures.
The iFR Modality is intended to be used in conjunction with currently marketed Volcano pressure wires. In the coronary anatomy, the iFR modality has a diagnostic cut-point of 0.89 which represents an ischemic threshold and can reliably guide revascularization decisions during diagnostic catheterization procedure. When used as for a pullback assessment, the iFR modality is intended as a visual aid in decision making by indicating the relative location and severity of the stenoses such as, multiple lesions or diffuse disease.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K203719 · printed Nov 6, 2026
Cite this page
510(k) Report. “K203719: IntraSight Mobile.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K203719
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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