Interventional Workspot - Software medical device hosting platform, used - Philips Medical Systems Nederland B.V.

Duns Number:413819707

Device Description: Software medical device hosting platform, used with a Philips Interventional X-Ray System. Software medical device hosting platform, used with a Philips Interventional X-Ray System. Provides common functionalities (e.g. import / export, data handling) for other software medical devices.

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

001000

Brand Name

Interventional Workspot

Version/Model Number

Interventional Workspot - 1

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K121296,K181177

Product Code Details

Product Code

LLZ

Product Code Name

System, Image Processing, Radiological

Device Record Status

Public Device Record Key

84c067b4-5fd0-4465-a548-5897eb67196b

Public Version Date

November 13, 2020

Public Version Number

8

DI Record Publish Date

September 24, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"PHILIPS MEDICAL SYSTEMS NEDERLAND B.V." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 349