510(k) · Cleared
Recalled · Class II · 2026IntraSight Plus
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Philips Image Guided Therapy Corporation · IYO System, Imaging, Pulsed Echo, Ultrasonic
Cleared on Feb 24, 2026 as substantially equivalent to K190078 (Volcano Corporation, 2019) and 1 other predicate after a 92-day review. Its family tree reaches back 14 generations to 1995. It has been recalled once.
- Decided
- Feb 24, 2026
- Review
- 92 days
- Class
- Class II
- Product code
- IYO
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 14 generations to K934139 (1995). 53 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 deviceK253714 IntraSight PlusPhilips Image Guided Therapy Corporation · 2026
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 deviceK253714 IntraSight PlusPhilips Image Guided Therapy Corporation · 2026
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) | K253714 | IntraSight Plus | Philips Image Guided Therapy Corporation | 2026 | — |
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 |
| 2019 | 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? (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 |
|---|---|---|---|
| * | K190078 | IntraSightSummary page 5…DSA IYO OWB Predicate Device(s): 510(k) No. Device Name Product Code(s) K190078 IntraSight System IYO, DSA, DSK K190626 SyncVision System… | 2019 |
| * | K190626 | SyncVision SystemSummary page 5…Device Name Product Code(s) K190078 IntraSight System IYO, DSA, DSK K190626 SyncVision System OWB Device Description: Philips IntraSight Plus is a multi-modality, application-ba… | 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 |
|---|---|---|---|---|
| Aug 6, 2026 | Class II | Z-3276-2026 | Software Design Change | Software system may associate image data from one patient with another patient's record, potentially resulting in incorrect diagnosis or treatment. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 31 years and passes through 6 companies; a new generation was cleared every 2.1 years on median.
- 8 of the 53 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. 2026, 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?
IntraSight Plus is a multi-function system intended to be used as an adjunct diagnostic tool for qualitative and quantitative evaluation of vascular morphology in coronary arteries and peripheral vasculature in patients eligible for endovascular procedures. The system, when configured with optional features, can also be used for: - quantitative evaluation of coronary physiology using pressure-derived ratios, - quantitative evaluation of coronary artery…
Read the full statement (201 words)
IntraSight Plus is a multi-function system intended to be used as an adjunct diagnostic tool for qualitative and quantitative evaluation of vascular morphology in coronary arteries and peripheral vasculature in patients eligible for endovascular procedures.
The system, when configured with optional features, can also be used for:
- quantitative evaluation of coronary physiology using pressure-derived ratios,
- quantitative evaluation of coronary artery dimensions,
- enhanced visualization of stent or balloon placement in coronary arteries, and
- co-registration of an x-ray image with coronary intravascular ultrasound and/or coronary pressure-derived ratios
in patients eligible for percutaneous coronary intervention.
The IntraSight Plus IVUS function is indicated for use in patients undergoing conventional angiographic procedure to assess vascular morphology and to assess the need for additional treatment post percutaneous intervention. IVUS is obtained with a compatible ultrasound catheter and used as an adjunct to examine vascular morphology in the coronary arteries and vessels of the peripheral vasculature.
The IntraSight Plus FFR and iFR functions are indicated for use in patients with signs of coronary artery disease undergoing coronary catheterization procedures to assess the hemodynamic significance of coronary lesions that may contribute to myocardial ischemia. FFR and iFR are obtained with a compatible pressure guide wire.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K253714 · printed Nov 6, 2026
Cite this page
510(k) Report. “K253714: IntraSight Plus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K253714
Report an extraction error
Are you the manufacturer?
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