510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K001097Substantially Equivalent

Active Array Catheter, Model Cs-2000

Image-Guided Neurologics, Inc., Melbourne FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K001097 is the FDA 510(k) clearance record for ACTIVE ARRAY CATHETER, MODEL CS-2000, a class II device, cleared for Image-Guided Neurologics, Inc. on under FDA product code MOS (Coil, Magnetic Resonance, Specialty). FDA records list 22 510(k) clearances for Image-Guided Neurologics, Inc., from to . As of , FDA records show no recalls naming K001097.

Clearance record

Decision date
Received
(289 days to decision)
Product code
MOS Coil, Magnetic Resonance, Specialty
Regulation
21 CFR 892.1000
Device class
Class II
Review panel
Radiology
Applicant
Image-Guided Neurologics, Inc. 2290 Eau Gallie Blvd., Melbourne FL
510(k) summary
Statement
Third party review
No

Clearances, product code MOS

Trailing 12 months
9 clearances under product code MOS in the twelve months to October 2026, April 2026 the highest month at 3.
Show the numbers
Monthly 510(k) clearances under FDA product code MOS, trailing twelve months
MonthClearances
November 20250
December 20250
January 20262
February 20261
March 20261
April 20263
May 20260
June 20260
July 20262
August 20260
September 20260
October 20260