# K151613: iLab Polaris Multi-Modality Guidance System

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific Corporation
- Decided: Oct 6, 2015 after 113 days
- Product code: DQK (Computer, Diagnostic, Programmable)
- Device class: 2
- Regulation: 21 CFR 870.1425
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K003122 (2001). 17 ancestors in all.
10 later devices descend from it; 2 cite it directly.
0 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092105: Radianalyzer Xpress, Radi Medical Systems AB (2009) Summary page 4.
- K130243: Ilab Ultrasound Imaging System, Boston Scientific Corp (2013) Summary page 4.

## Most influential descendants
- K191008: iLab Polaris Multi-Modality Guidance System (2019), 8 descendants of its own
- K201178: iLab Polaris Multi-Modality Guidance System (2020), 6 descendants of its own
- K210889: iLab Polaris Multi-Modality Guidance System (2021), 4 descendants of its own
- K201713: AVVIGO Guidance System (2020), 4 descendants of its own
- K212490: AVVIGO Guidance System II (2021), 3 descendants of its own

## Indications for use
The IVUS modality of the iLab Polaris Multi-Modality Guidance System is intended for ultrasound examinations of intravascular pathology. Intravascular ultrasound is indicated in patients who are candidates for transluminal interventional procedures such as angioplasty and atherectomy. Indications for Auto Pullback Use Automatic Pullback is indicated when the following occurs: • The physician/operator wants to standardize the method in which intravascular ultrasound images are obtained and documented: procedure-to-procedure, operator-to-operator. • The physician/operator wants to make linear distance determinations post-procedurally, which requires the imaging core of a catheter to be pulled back at a known uniform speed. • Two-dimensional, longitudinal reconstruction of the anatomy is desired. The FFR modality of the iLab Polaris Multi-Modality Guidance System is intended for use in catheterization and related cardiovascular specialty laboratories to compute, and display various physiological parameters based on the output from one or more electrodes, transducers or measuring devices. This modality is indicated to provide hemodynamic information for use in the diagnosis and treatment of patients that undergo measurement of physiological parameters, Fractional Flow Reserve (FFR).

Source page: https://510kreport.com/device/K151613
Methodology: https://510kreport.com/methodology