Genesis MNS with Model-S

FDA UDI

Class II (US FDA UDI)

by Stereotaxis, Inc.

Identity

Trade Name: Genesis MNS with Model-S FDA UDI
Generic Name: Robotic surgical navigation system FDA UDI
Device Name: "Genesis MNS is intended to navigate compatible magnetic devices through tissue to designated target sites in the right and left heart and coronary vasculature, neurovascular and peripheral vasculature by orienting the device tip in a desired direction. " FDA UDI
Model / Reference: 1.1 Model-S FDA UDI
Description: "Genesis MNS is intended to navigate compatible magnetic devices through tissue to designated target sites in the right and left heart and coronary vasculature, neurovascular and peripheral vasculature by orienting the device tip in a desired direction. " FDA UDI

Identifiers

Catalog Number: 001-011000-3 FDA UDI
Primary DI / UDI-DI: M58800101100030 FDA UDI
510(k) Number: K193147 FDA UDI
FDA Product Code: PJB FDA UDI
NDQ FDA UDI
GMDN Term: Robotic surgical navigation system FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 870.5700 FDA UDI
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

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Robotic surgical navigation system

Genesis MNS with Model-S by Stereotaxis, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Robotic surgical navigation system.

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EXCELSIUSGPS — GLOBUS MEDICAL, INC. · Class II
SI-LOK — GLOBUS MEDICAL, INC. · Class II
EXCELSIUS GPS — GLOBUS MEDICAL, INC. · Class II

Cleared under the same submission

K193147 also covers:

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 888c8dad-7934-4641-810e-6a929b829ae8 36 fields · synced May 30, 2026