Cleared Traditional

K183320 - Ilumien Optis

K183320 is an FDA 510(k) clearance for Ilumien Optis, manufactured by St. Jude Medical (Now Abbott Medical). The device is a Class 2 Cardiovascular device with product code NQQ cleared through the Traditional 510(k) pathway after a 123-day FDA review.

K183320 · St. Jude Medical (Now Abbott Medical) · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2019
Decision
123d
Days
Class 2
Risk

K183320 is an FDA 510(k) clearance for the Ilumien Optis, Optis Integrated, Optis Mobile. Classified as System, Imaging, Optical Coherence Tomography (oct) (product code NQQ), Class II - Special Controls.

Submitted by St. Jude Medical (Now Abbott Medical) (St. Paul, US). The FDA issued a Cleared decision on April 2, 2019 after a review of 123 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 892.1560 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all St. Jude Medical (Now Abbott Medical) devices

FDA 510(k) Submission Details - K183320

510(k) Number K183320 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 30, 2018
Decision Date April 02, 2019
Days to Decision 123 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
2d faster than avg
Panel avg: 125d · This submission: 123d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NQQ Device Classification - Class 2, Special Controls

Product Code NQQ System, Imaging, Optical Coherence Tomography (oct)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1560
Definition This Device Uses Back-reflected Light To Create Two-dimensional Images Versus Back-reflected Sound Waves As Are Used In Ultrasound Imaging.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - NQQ System, Imaging, Optical Coherence Tomography (oct)

All 24
Devices cleared under the same product code (NQQ) and FDA review panel - the closest regulatory comparables to K183320.
ApolloVue S100 Image System
K201552 · Apollo Medical Optics, Ltd. · Sep 2020
Gentuity HF-OCT Imaging System with Vis-Rx Micro-Imaging Catheter
K192922 · Gentuity, LLC · Feb 2020
NvisionVLE Low-profile Optical Probe
K191117 · Ninepoint Medical, Inc. · Jul 2019
OTIS Optical Coherence Tomography SYstem
K190404 · Perimeter Medical Imaging, Inc. · Mar 2019
NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation System
K182616 · Ninepoint Medical, Inc. · Nov 2018
NvisionVLE Imaging System, NvisionVLE Optical Probe
K182261 · Ninepoint Medical, Inc. · Oct 2018