Ox-Imager CS

FDA 510(k) K153426 · Modulated Imaging, Inc.

Substantially Equivalent

510(k) numberK153426

Submission

Device name
Ox-Imager CS
Applicant
Modulated Imaging, Inc.
Irvine, CA, US
Received
November 25, 2015
Decision date
December 21, 2016
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
MUD – Oximeter, Tissue Saturation
Device class
Class II (moderate risk)
Regulation
21 CFR 870.2700
Specialty
Cardiovascular

Other 510(k)s with product code MUD

510(k)DeviceApplicantDecision
K254129Spectrum-2MUD · Traditional Neko Health AB05/22/2026SE
K243324Masimo O3 Regional OximeterMUD · Traditional Masimo Corporation07/17/2025SE
K250519Lap.Ox™ Laparoscopic Tissue OximeterMUD · Traditional ViOptix, Inc.06/26/2025SE
K240596Cerebral Autoregulation Index (CAI) AlgorithmMUD · Traditional Edwards Lifesciences10/16/2024SE
K241393ODI-TechMUD · Traditional Odi Medical AS08/30/2024SE
K240601SnapshotNIR model KD205MUD · Traditional Kent Imaging, Inc.04/02/2024SE
K232385OxiplexTS200MUD · Traditional Iss Medical, Inc.03/01/2024SE
K233488Intra.Ox™ 2.0 Handheld Tissue OximeterMUD · Traditional Vioptix, Inc.02/28/2024SE
K230612Edwards Algorithm for Measurement of Blood HemoglobinMUD · Traditional Edwards Lifesciences, LLC11/17/2023SE
K223651Cerebral Adaptive Index (CAI) AlgorithmMUD · Traditional Edwards Lifesciences, LLC05/26/2023SE

More from Edwards Lifesciences, LLC

510(k)DeviceDecision
K181623Clarifi Imaging SystemMUD · Special 07/19/2018SE

Questions and answers

When was Ox-Imager CS cleared by the FDA?

Ox-Imager CS (K153426) received a 510(k) decision of Substantially Equivalent on December 21, 2016, 392 days after the submission was received.

What is the product code of K153426?

The FDA product code is MUD – Oximeter, Tissue Saturation, a Class II (moderate risk) device regulated under 21 CFR 870.2700.