Niobe MNS Philips

FDA UDI

Class II (US FDA UDI)

by Stereotaxis, Inc.

Identity

Trade Name: Niobe MNS Philips FDA UDI
Generic Name: Cardiac mapping system workstation FDA UDI
Device Name: Stereotaxis Niobe Magnetic Navigation System (MNS) with Navigant Navigation Workstation. The Niobe MNS with Navigant NWS is intended to navigate compatible magnetic devices through tissue to designated target sites in the right and left heart, coronary vasculature, neurovasculature and peripheral vasculature by orienting the device tip in a desired direction FDA UDI
Model / Reference: ES Philips FDA UDI
Description: Stereotaxis Niobe Magnetic Navigation System (MNS) with Navigant Navigation Workstation. The Niobe MNS with Navigant NWS is intended to navigate compatible magnetic devices through tissue to designated target sites in the right and left heart, coronary vasculature, neurovasculature and peripheral vasculature by orienting the device tip in a desired direction FDA UDI

Identifiers

Catalog Number: 001-006100-1 FDA UDI
Primary DI / UDI-DI: M58800100610010 FDA UDI
510(k) Number: K060967 FDA UDI
FDA Product Code: NDQ FDA UDI
GMDN Term: Cardiac mapping system workstation FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 870.1290 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

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Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Cardiac mapping system workstation

Niobe MNS Philips by Stereotaxis, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K060967 also covers:

Niobe MNS Siemens — Stereotaxis, Inc.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Stereotaxis, Inc.

Sources (1)

FDA UDI 42d65308-245f-4c8e-9a43-559157384413 36 fields · synced Jun 1, 2026