Cleared Traditional

K253459 - OPTIS Mobile Next Imaging System (1014932) (FDA 510(k) Clearance)

Also includes:
OPTIS Integrated Next Imaging System (1014933) Ultreon 3.0 Software Upgrade Kit (ULTR300001)

Class II Cardiovascular device cleared through predicate-based substantial equivalence.

K253459 · Abbott Medical · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2026
Decision
199d
Days
Class 2
Risk

K253459 is an FDA 510(k) clearance for the OPTIS Mobile Next Imaging System (1014932). Classified as System, Imaging, Optical Coherence Tomography (oct) (product code NQQ), Class II - Special Controls.

Submitted by Abbott Medical (Westford, US). The FDA issued a Cleared decision on April 24, 2026 after a review of 199 days - an extended review cycle.

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 Abbott Medical devices

Submission Details

510(k) Number K253459 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 07, 2025
Decision Date April 24, 2026
Days to Decision 199 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
74d slower than avg
Panel avg: 125d · This submission: 199d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Cardiovascular devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT04356027 Completed Observational Industry-sponsored

FUnctional diagnoSIs of corONary Stenosis (FUSION)

Validation of OCT-based FUnctional diagnoSIs of corONary Stenosis (FUSION)

312
Patients (actual)
28
Sites
Condition studied Coronary Artery Disease; Coronary Stenosis
Eligibility All sexes · 18 Years+
Principal investigator Allen Jeremias, MD
Sponsor Abbott Medical Devices (industry)
Started 2020-06-26 → Primary completion 2021-10-15
Primary outcome
Sensitivity and Specificity of Virtual Flow Reserve (VFR) Against Fractional Flow Reserve (FFR)
Secondary outcome
Overall Diagnostic Accuracy
View full study on ClinicalTrials.gov

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

All 45
Devices cleared under the same product code (NQQ) and FDA review panel - the closest regulatory comparables to K253459.
LIA Console (542-7)
K251730 · Leadoptik, Inc. · Dec 2025
HyperVue™ Imaging System - Integrated
K253101 · Spectrawave, Inc. · Dec 2025
deepLive (OSP12 + DMS)
K252851 · Damae Medical · Oct 2025
HyperVue™ Software
K251198 · Spectrawave, Inc. · Jul 2025
OPUSWAVE Dual Sensor Imaging System
K250684 · Terumo Cardiovascular Systems Thi Plant · Jul 2025
OPXION Optical Skin Viewer (OPXSV1-01F)
K242924 · Opxion Technology, Inc. · Jun 2025