Vivid Focus X v211 / TC001006

Organization name

GE Vingmed Ultrasound AS

SRN

NO-MF-000000553

Manufacturer status

Active

2 warnings recorded — scroll inside the panel to see all entries.

• CW027

  EUDAMED did not publish a description for this code.
• CW010

  The ultrasound unit is not intended for ophthalmic use or any use causing the acoustic beam to pass through the eye.

Primary placement in Norway; available across 32 countries total.

Trade name

not provided

UDI-DI code

00198953040270

Basic UDI-DI

08406821BUG0061173

Reference / catalog number

Vivid Focus X v211 / TC001006

Issuing entity

GS1

Risk category

Class IIa

Applicable legislation

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

Status

On the market

Quantity

1

Additional product description

Vivid Focus is a diagnostic ultrasound system, which is primarily intended for cardiac imaging and analysis but also includes vascular and general radiology applications.

Additional information URL

http://www.gehealthcare.com/DocumentationLibrary

Clinical sizes

No clinical sizes registered for this device.

European Medical Device Nomenclature — the EU product classification assigned to this device.

• Z11040102CARDIOLOGY ULTRASOUND SCANNERS