# K253714: IntraSight Plus

- Pathway: 510(k) (Traditional)
- Applicant: Philips Image Guided Therapy Corporation
- Decided: Feb 24, 2026 after 92 days
- Product code: IYO (System, Imaging, Pulsed Echo, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1560
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 14 generations back to K934139 (1995). 53 ancestors in all.
No later device cites it as a predicate yet.
0 of 54 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K190078: IntraSight, Volcano Corporation (2019) Summary page 5.
- K190626: SyncVision System, Volcano Corporation (2019) Summary page 5.

## Recalls of this device
- Aug 6, 2026 · Class II · Z-3276-2026: Software system may associate image data from one patient with another patient's record, potentially resulting in incorrect diagnosis or treatment.

## Indications for use
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.

Source page: https://510kreport.com/device/K253714
Methodology: https://510kreport.com/methodology