HyperView Hyperspectral Tissue Oxygenation Measurement System— 510(k) K161237

Name: FDA 510(k) clearance K161237
Creator: U.S. Food and Drug Administration
Published: 2016-12-16

Substantially Equivalent

Hypermed Imaging, Inc.

FDA 510(k) clearance K161237 for HyperView Hyperspectral Tissue Oxygenation Measurement System, Substantially Equivalent on 2016-12-16. Applicant: Hypermed Imaging, Inc.. Device class: 2.

Clearance details

Applicant: Hypermed Imaging, Inc.
Product code: Code MUD
Device class: Class 2
Regulation: 21 CFR 870.2700
Advisory panel: Cardiovascular
Date received: 2016-05-02
Decision date: 2016-12-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Memphis, TN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code MUD

view all

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

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.