# K191008: iLab Polaris Multi-Modality Guidance System

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific Corporation
- Decided: Jul 2, 2019 after 77 days
- Product code: DQK (Computer, Diagnostic, Programmable)
- Device class: 2
- Regulation: 21 CFR 870.1425
- 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: 7 generations back to K003122 (2001). 18 ancestors in all.
8 later devices descend from it; 2 cite it directly.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151613: iLab Polaris Multi-Modality Guidance System, Boston Scientific Corporation (2015) Summary page 4.

## Most influential descendants
- 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
- K230884: AVVIGO'+ Multi-Modality Guidance System (2023), 1 descendant of its own

## Recalls of this device
- Sep 18, 2019 · Class II · Z-1804-2020: Certain iLab Polaris Systems which were upgraded with a previous 2.10 software version (disk batch 629774) contained a bug in which only the True Color Secondary Capture (SC) format will archive Diast

## 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, FFR and DFR™ are 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. FFR and DFR are indicated to provide hemodynamic information for use in the diagnosis and treatment of patients that undergo measurement of physiological parameters. The Imaging Catheters generate ultrasound images and are intended for ultrasound examination of vascular and cardiac pathology. Boston Scientific manufactures a wide variety of catheters for different applications. The recommended use of each of these catheters may vary depending on the size and type of the catheter. Please refer to the Imaging Catheter Directions for Use, packaged with each catheter. Indications for Auto Pullback Use (IVUS Only) 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.

Source page: https://510kreport.com/device/K191008
Methodology: https://510kreport.com/methodology