666601

Organization name

eemagine Medical Imaging Solutions GmbH

SRN

DE-MF-000005560

Manufacturer status

Active

1 warning recorded — scroll inside the panel to see all entries.

• CW010

  visor2 is a 3D navigation system, and, as such, has no contraindications. The TMS stimulator used with visor2 may have contraindications. Warning: Before performing transcranial magnetic stimulation, read carefully the complete list of contraindications in the documentation of your TMS stimulator.

Primary placement in Germany; available across 31 countries total.

Trade name

not provided

UDI-DI code

+B195666601

Basic UDI-DI

++B1956666016N

Reference / catalog number

666601

Issuing entity

HIBCC

Risk category

Class IIa

Applicable legislation

MDR [Regulation (EU) 2017/745 on medical devices]

Status

On the market

Quantity

1

Additional product description

The visor2 is used to aid 3D navigation for positioning of Transcranial Magnetic Stimulation (TMS) coils over preselected brain regions in scientific research or clinical procedures. The visor2 is to be used with a compatible TMS stimulator, a compatible optical tracking system and further compatible accessories. Optionally, a compatible amplifier for measuring electrophysiological signals can be connected. The visor2 allows to record and view electrophysiological signals from the patient. It visualizes the activated functional cortex area over the anatomical images of the patient's brain based on the analysis of the patient's response after the application of a TMS pulse. The software and system on which it is installed must be operated by, or under the supervision of, a medical practitioner or investigator who has knowledge about the principles of TMS, physiology, and potential side effects, and must not be used during surgical operations.

Additional information URL

https://academy.ant-neuro.com/

Clinical sizes

No clinical sizes registered for this device.

• Z12109099VARIOUS NEUROLOGY AND NEUROSURGERY INSTRUMENTS - OTHER

• Batch number
• Expiration date
• Manufacturing date
• Serial number
• Software identification