Intra.Ox Handheld Tissue Oximeter— 510(k) K163472

Name: FDA 510(k) clearance K163472
Creator: U.S. Food and Drug Administration
Published: 2017-11-16

Substantially Equivalent

Vioptix, Inc.

FDA 510(k) clearance K163472 for Intra.Ox Handheld Tissue Oximeter, Substantially Equivalent on 2017-11-16. Applicant: Vioptix, Inc.. Device class: 2.

Clearance details

Applicant: Vioptix, Inc.
Product code: Code MUD
Device class: Class 2
Regulation: 21 CFR 870.2700
Advisory panel: Cardiovascular
Date received: 2016-12-12
Decision date: 2017-11-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Newark, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code MUD

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K254129 — Spectrum-22026-05-22
K243324 — Masimo O3 Regional Oximeter2025-07-17
K250519 — Lap.Ox Laparoscopic Tissue Oximeter2025-06-26
K240596 — Cerebral Autoregulation Index (CAI) Algorithm2024-10-16
K241393 — ODI-Tech2024-08-30

More clearances from Vioptix, Inc.

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K233488 — Intra.Ox 2.0 Handheld Tissue Oximeter2024-02-28
K221010 — Intra.Ox 2.0 Handheld Tissue Oximeter2022-05-03
K191676 — Intra.Ox 2.0 Handheld Tissue Oximeter2019-09-16
K133983 — INTRA. OX HANDHELD TISSUE OXIMETER2014-09-12
K141234 — ODISSEY TISSUE OXIMETER2014-07-01

Adverse events under product code MUD

product code MUD

Malfunction: 467
Total: 467

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.