Azurion 7 B20

Organization name

Philips Medical Systems Nederland B.V.

SRN

NL-MF-000001489

Manufacturer status

Active

Certificate health across this manufacturer's portfolio.

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

• CW999

  Avoid using the system with patients who are pregnant or who may possibly be pregnant. H
• CW999

  Avoid using the system with patients who are pregnant or who may possibly be pregnant. However, the risk may be outweighed by the benefit of diagnosing or treating a serious condition. It is the responsibility of the personnel operating the system to make the decision. Avoid using the system in case of existing radiation injury (operator or patient).

Primary placement in Netherlands; available across 28 countries total.

Trade name

Azurion 7 B20

UDI-DI code

00884838116801

Basic UDI-DI

0884838BM328SX

Reference / catalog number

722236

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

Biplane Interventional X-Ray System with floor-mounted frontal stand (20-inch flat detector), ceiling-mounted lateral stand (12-inch or 15-inch flat detector) and optional interface for an OR table.

Additional information URL

http://www.philips.com/doc_library%20(http://www.philips.com/doc_library)

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.

• Z11030102STATIONARY ANGIOGRAPHY SYSTEMS FOR ANGIOGRAPHIC AND CARDIOLOGIC STUDIES