Brilliance Big Bore System Upgrade

Organization name

Philips Medical Systems Nederland B.V.

SRN

NL-MF-000001489

Manufacturer status

Active

Certificate health across this manufacturer's portfolio.

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

• CW018

  EUDAMED did not publish a description for this code.
• CW013

  CAUTION - Laser Radiation. Do not stare into beam. Class 2 laser product, 1mW maximum output. Wavelength 650nm. IEC/EN 60825-1:2014
• CW999

  Hazardous Voltage. Electric schock hazard exists behind cover. Restrict service to qualified personnel only. Can result in electrocution or death.
• CW999

  UPS voltage may be present when power is off. Conract may cause electric shock or burn. Turn off and lock out UPS output power before servicing.
• CW999

  Caution, Class 3B invisible laser radiation when open and interlocks defeated. Avoid exposure to the beam and use laser safety goggles. 150 mW MAX. OUTPUT WAVELENGTH 850 nm IEC 60825-1:2014.

Primary placement in Germany; available across 27 countries total.

Trade name

Brilliance Big Bore System Upgrade

UDI-DI code

00884838098725

Basic UDI-DI

0884838BM277T7

Reference / catalog number

728272

Issuing entity

GS1

Risk category

Class IIb

Applicable legislation

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

Status

On the market

Quantity

1

Additional product description

The Brilliance Big Bore system is Computed Tomography X-Ray intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes.

Additional information URL

https://www.philips.com/ifu

Clinical sizes

No clinical sizes registered for this device.

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

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

• Z11030603COMPUTED TOMOGRAPHS - 16 LAYERS OR MORE BUT LESS THAN 64 LAYERS