IntelliSpace Clinical Applications - Philips IntelliSpace Clinical Applications is an - Philips Healthcare Informatics, Inc.

Duns Number:095471327

Device Description: Philips IntelliSpace Clinical Applications is an image processing workstation software pac Philips IntelliSpace Clinical Applications is an image processing workstation software package designed to run on standard PC hardware. The hardware required is made up of "off-the-shelf" standard computer components. Philips IntelliSpace Clinical Applications software receives image data from medical scanning devices, such as CT and MRI, or from image archives. Philips IntelliSpace Clinical Applications performs viewing, image manipulation, communication, printing, and quantification of images.

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More Product Details

Catalog Number

837509

Brand Name

IntelliSpace Clinical Applications

Version/Model Number

8.x

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

K032096

Product Code Details

Product Code

LLZ

Product Code Name

System, image processing, radiological

Device Record Status

Public Device Record Key

aaef4766-a18b-4926-8cb4-fdc4f1461425

Public Version Date

October 31, 2018

Public Version Number

1

DI Record Publish Date

September 30, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"PHILIPS HEALTHCARE INFORMATICS, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 3