Cleared Special

iLab Polaris Multi-Modality Guidance System

K201178 · Boston Scientific · Cardiovascular
May 2020
Decision
28d
Days
Class 2
Risk

About This 510(k) Submission

K201178 is an FDA 510(k) clearance for the iLab Polaris Multi-Modality Guidance System, a Computer, Diagnostic, Programmable (Class II — Special Controls, product code DQK), submitted by Boston Scientific (Maple Grove Hennepin, US). The FDA issued a Cleared decision on May 29, 2020, 28 days after receiving the submission on May 1, 2020. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1425.

Submission Details

510(k) Number K201178 FDA.gov
FDA Decision Cleared SESE
Date Received May 01, 2020
Decision Date May 29, 2020
Days to Decision 28 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DQK — Computer, Diagnostic, Programmable
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1425

Similar Devices — DQK Computer, Diagnostic, Programmable

All 423
HemoSphere Nano Monitor (HSNANO1)
K253186 · Edwards Lifesciences, LLC · Feb 2026
CARTO? 3 EP Navigation System V8.4
K252972 · Biosense Webster, Inc. · Feb 2026
IOPS Visionary System (MC-3); IOPS Viewpoint Simple Curve Catheter, 75cm (C00751); IOPS Viewpoint Simple Curve Catheter, 125cm (C01251); IOPS Viewpoint Double Curve Catheter, 75cm (C00752); IOPS Viewpoint Double Curve Catheter, 125cm (C02152); IOPS Guidewire 2 (ATW-2); IOPS Fiducial Tracking Pad (T02111); IOPS Guidewire Handle (H01035)
K254089 · Centerline Biomedical, Inc. · Feb 2026
Holter ECG and ABP system (HolterABP)
K251591 · Edan Instruments, Inc. · Feb 2026
SafeBeat Rx App
K251218 · Safebeat Rx, Inc. · Feb 2026
NorthStar? Mapping System
K252164 · Imricor Medical Systems · Jan 2026