Niobe® Magnetic Navigation System (MNS) with Navigant Workstation (NWS) and Cardiodri— 510(k) K192775

Name: FDA 510(k) clearance K192775
Creator: U.S. Food and Drug Administration
Published: 2019-10-30

Substantially Equivalent

Stereotaxis, Inc.

FDA 510(k) clearance K192775 for Niobe® Magnetic Navigation System (MNS) with Navigant Workstation (NWS) and Cardiodri, Substantially Equivalent on 2019-10-30. Applicant: Stereotaxis, Inc.. Device class: 2.

Clearance details

Applicant: Stereotaxis, Inc.
Product code: Code PJB
Device class: Class 2
Regulation: 21 CFR 870.5700
Advisory panel: Cardiovascular
Date received: 2019-09-30
Decision date: 2019-10-30
Decision: Substantially Equivalent
Clearance type: Special
Location: St. Louis, MO, US

Download summary PDF View on FDA.gov ↗

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More clearances from Stereotaxis, Inc.

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K262744 — GenesisX RMN2026-08-27
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K150312 — Vdrive system, Vdrive Duo, Vdrive with V-Sono2015-06-17

Recalls naming K192775

K-number listed on FDA's recall record

Z-0430-2021 — Niobe ES System, Models 001-006000-1 and 001-006100-1Class II·Terminated·Stereotaxis Inc·20200921

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K192775.

Data sourced from openFDA. This site is unofficial and independent of the FDA.