510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K161237Substantially Equivalent

HyperView Hyperspectral Tissue Oxygenation Measurement System

Hypermed Imaging, Inc., Memphis TN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K161237 is the FDA 510(k) clearance record for HyperView Hyperspectral Tissue Oxygenation Measurement System, a class II device, cleared for Hypermed Imaging, Inc. on under FDA product code MUD (Oximeter, Tissue Saturation). FDA records list one 510(k) clearance for Hypermed Imaging, Inc. As of , FDA records show no recalls naming K161237.

Clearance record

Decision date
Received
(228 days to decision)
Product code
MUD Oximeter, Tissue Saturation
Regulation
21 CFR 870.2700
Device class
Class II
Review panel
Cardiovascular
Applicant
Hypermed Imaging, Inc. 8700 Trl. Lake Dr. W., Suite 200, Memphis TN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MUD

Trailing 12 months
1 clearance under product code MUD in the twelve months to October 2026, May 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code MUD, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20261
June 20260
July 20260
August 20260
September 20260
October 20260