510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K070358Substantially Equivalent

Maxinsight

Eemagine Medical Imaging Solutions GmbH, Deer Field IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K070358 is the FDA 510(k) clearance record for MAXINSIGHT, a class II device, cleared for Eemagine Medical Imaging Solutions GmbH on under FDA product code OLX (Source Localization Software For Electroencephalograph Or Magnetoencephalograph). FDA's definition for product code OLX reads: "Correlation of electrical activity of the brain using various neuroimaging modalities for source-localization". FDA records list 8 510(k) clearances for Eemagine Medical Imaging Solutions GmbH, from to . As of , FDA records show no recalls naming K070358.

Clearance record

Decision date
Received
(173 days to decision)
Product code
OLX Source Localization Software For Electroencephalograph Or Magnetoencephalograph
Regulation
21 CFR 882.1400
Device class
Class II
Review panel
Neurology
Applicant
Eemagine Medical Imaging Solutions GmbH P.O. Box 7007, Deer Field IL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OLX

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