Cleared Traditional

K153426 - Ox-Imager CS

K153426 is an FDA 510(k) clearance for Ox-Imager CS, manufactured by Modulated Imaging, Inc.. The device is a Class 2 Cardiovascular device with product code MUD cleared through the Traditional 510(k) pathway after a 392-day FDA review.

K153426 · Modulated Imaging, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2016
Decision
392d
Days
Class 2
Risk

K153426 is an FDA 510(k) clearance for the Ox-Imager CS. Classified as Oximeter, Tissue Saturation (product code MUD), Class II - Special Controls.

Submitted by Modulated Imaging, Inc. (Irvine, US). The FDA issued a Cleared decision on December 21, 2016 after a review of 392 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2700 - 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. Elevated predicate reliance profile. 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 Modulated Imaging, Inc. devices

FDA 510(k) Submission Details - K153426

510(k) Number K153426 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 25, 2015
Decision Date December 21, 2016
Days to Decision 392 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
267d slower than avg
Panel avg: 125d · This submission: 392d
Pathway characteristics
Predicate-based equivalence.

MUD Device Classification - Class 2, Special Controls

Product Code MUD Oximeter, Tissue Saturation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2700
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.

Regulatory Consultant

O'Connell Regulatory Consultants, Inc.
MAUREEN O'CONNELL

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Clinical Evidence

ClinicalTrials.gov
NCT01484730 Recruiting Observational

A Pilot Study to Evaluate Multi-Spectral and Laser Speckle Imaging and Multiphoton Microscopy During Vascular Occlusion

A Pilot Study to Evaluate Multi-Spectral Imaging (MI) and Laser Speckle Imaging (LSI) and Multiphoton Microscopy (MPM) During Vascular Occlusion

150
Patients (est.)
1
Site
Condition studied Abnormal Vascular Flow
Eligibility All sexes · 18 Years+ · Healthy volunteers accepted
Principal investigator Anthony Durkin, PhD
Sponsor University of California, Irvine
Started 2011-11-01 → Primary completion 2026-08-01 → Completed 2028-08-01
Primary outcome
Skin blood flow
View full study on ClinicalTrials.gov

Regulatory Peers - MUD Oximeter, Tissue Saturation

All 73
Devices cleared under the same product code (MUD) and FDA review panel - the closest regulatory comparables to K153426.
Intra.Ox Handheld Tissue Oximeter
K163472 · Vioptix, Inc. · Nov 2017
Masimo O3 Regional Oximeter System
K162603 · Masimo Corporation · May 2017
Kent Camera
K163070 · Kent Imaging, Inc. · May 2017
HyperView Hyperspectral Tissue Oxygenation Measurement System
K161237 · Hypermed Imaging, Inc. · Dec 2016
NIRO-200NX DP
K162117 · Hamamatsu Photonics K.K. · Oct 2016
Masimo O3 Regional Oximeter System
K160526 · Masimo Corporation · Jun 2016