V-Sono Intracardiac Echo Manipulator

FDA UDI

Class II (US FDA UDI)

by Stereotaxis, Inc.

Identity

Trade Name: V-Sono Intracardiac Echo Manipulator FDA UDI
Generic Name: Cardiac mapping system workstation FDA UDI
Device Name: Vdrive with V-Sono is indicated for remotely controlling the advancement, retraction, rotation and anterior-posterior deflection of compatible ultrasound catheters inserted into the right atrium FDA UDI
Model / Reference: 1 FDA UDI
Description: Vdrive with V-Sono is indicated for remotely controlling the advancement, retraction, rotation and anterior-posterior deflection of compatible ultrasound catheters inserted into the right atrium FDA UDI

Identifiers

Catalog Number: 001-002469-1 FDA UDI
Primary DI / UDI-DI: M58800100246910 FDA UDI
510(k) Number: K122659 FDA UDI
FDA Product Code: DXX FDA UDI
DQX FDA UDI
GMDN Term: Cardiac mapping system workstation FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 870.1290 FDA UDI
870.1330 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

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

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Cardiac mapping system workstation

V-Sono Intracardiac Echo Manipulator by Stereotaxis, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Cardiac mapping system workstation.

CorPath GRX Cassette — Corindus, Inc. · Class II
CorPath GRX Extended Reach Arm — Corindus, Inc. · Class II
CorPath GRX Robotic Drive — Corindus, Inc. · Class II
CorPath GRX Cassette Duo — Corindus, Inc. · Class II
vMap Disposables — Vektor Medical, Inc. · Class II
CorPath GRX Drape, Control Console — Corindus, Inc. · Class II
CorPath GRX Drive Gear — Corindus, Inc. · Class II
CorPath GRX Extended Reach Arm — Corindus, Inc. · Class II

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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Stereotaxis, Inc.

Sources (1)

FDA UDI 8a168434-5413-4d7e-8871-cc2da5ae37f1 37 fields · synced Jun 8, 2026