510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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DEN250002Unknown

Delphi-MD System

Quantalx Neuroscience, Kfar-Saba, IL / Direct, Unknown
FDA source (opens on fda.gov)

DEN250002 is the FDA 510(k) clearance record for Delphi-MD System, a class II device, cleared for Quantalx Neuroscience, Ltd. on under FDA product code SFN (Non-Invasive Evoked Response Brain Stimulator). FDA's definition for product code SFN reads: "A non-invasive evoked response brain stimulator is a non-penetrating device used to apply a stimulus to the brain for the purpose of measuring the evoked brain activity response". FDA records list 3 510(k) clearances for Quantalx Neuroscience, Ltd., from to . As of , FDA records show no recalls naming DEN250002.

Clearance record

Decision date
Received
(229 days to decision)
Product code
SFN Non-Invasive Evoked Response Brain Stimulator
Regulation
21 CFR 882.1860
Device class
Class II
Review panel
Neurology
Applicant
Quantalx Neuroscience, Ltd. 1 Hatachana Kfar Saba, Kfar-Saba, IL
Third party review
No

Clearances, product code SFN

Trailing 12 months

FDA records hold no clearances under product code SFN in the trailing twelve months.

FDA records show no clearances under product code SFN in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code SFN, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260