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510(k) K001097

ACTIVE ARRAY CATHETER, MODEL CS-2000 by Image-Guided Neurologics, Inc. — Product Code MOS

K001097 is an FDA 510(k) premarket notification submitted by Image-Guided Neurologics, Inc. for the device "ACTIVE ARRAY CATHETER, MODEL CS-2000". The FDA issued a decision of Substantially Equivalent on January 18, 2001. The device falls under product code MOS (Coil, Magnetic Resonance, Specialty), a Class II device regulated under 21 CFR 892.1000. Image-Guided Neurologics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 18, 2001
Date Received
April 4, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Coil, Magnetic Resonance, Specialty
Device Class
Class II
Regulation Number
892.1000
Review Panel
RA
Submission Type

Other clearances by Image-Guided Neurologics, Inc.

  • K050772 — NAVIGUS REUSABLE PASSIVE PROBE, MODEL SP-2000 (April 21, 2005)
  • K043091 — NAVIGUS NEXDRIVE, MODEL MI-3000 (February 7, 2005)
  • K040334 — NAVIGUS PASSIVE PROBE, MODEL NP-1000 (October 4, 2004)
  • K040834 — NAVIGUS PASSIVE PROBE (BL), MODEL NP-2000 (June 3, 2004)
  • K033619 — NAVIGUS UNIBODY FIDUCIAL MARKER SYSTEM, MODEL FM-4000 (March 2, 2004)
  • K031885 — NAVIGUS PASSIVE HEAD RESTRAINT SYSTEM, MODEL HR-XXX (August 21, 2003)
  • K024201 — NAVIGUS FIDUCIAL MARKER SYSTEM, MODELS FM-1000, FM-2000 (March 12, 2003)
  • K023949 — NAVIGUS II TRAJECTORY GUIDE WITH VERIFICATION RETICULES (February 25, 2003)
  • K022100 — NAVIGUS MANUAL DISPOSABLE MICRODRIVE WITH DIGITAL DISPLAY, MODELS MI-1000 & MI-1 (September 25, 2002)
  • K012719 — NAVIGUS II MR (October 22, 2001)

Other clearances for product code MOS

  • K262330 — dS Breast 7ch 1.5TdS Breast 7ch 3.0TdS Breast 16ch 1.5TdS Breast 16ch 3.0TdS Bre (July 30, 2026)
  • K262294 — dS FootAnkle 16Ch 1.5T;dS FootAnkle 16Ch 3.0T;dS HiRes Hand/Wrist 16Ch 1.5T;dS H (July 24, 2026)
  • K260947 — 0.55T 12Ch Breast Coil (April 23, 2026)
  • K252587 — HD 8Ch Wrist Array (April 14, 2026)
  • K252876 — GEM Flex Coil 16-L Array, 3.0T Receive Only; GEM Flex Coil 16-M Array, 3.0T Rece (April 1, 2026)
  • K260519 — Smart Fit TorsoCardiac 1.5T (March 20, 2026)
  • K252179 — GEM Flex Coil 16-L Array, 1.5T Receive Only; GEM Flex Coil 16-M Array, 1.5T Rece (February 10, 2026)
  • K253738 — 3.0T AIR 32CH HNA (January 23, 2026)
  • K254190 — dS Base 1.5T; dS Base 3.0T; dS Head 1.5T; dS Head 3.0T; dS HeadNeck 1.5T; dS Hea (January 14, 2026)
  • K253182 — InkSpace Imaging Small Body Array (SBA12PH30x) (October 20, 2025)

FDA data resources