Duns Number:413819707
Device Description: illumeo system is a software package used with general purpose computing hardware to acqui illumeo system is a software package used with general purpose computing hardware to acquire, store, distribute, process and display images and associated data throughout a clinical environment. The software performs digital image processing, measurement, image manipulation, communication and storage. illumeo is offering a primary interpretation solution for reviewing and analysing a large variety of medical images deriving from various imaging modalities as well as non-imaging information. illumeo integrates with clinical imaging and non-imaging data sources to present in addition to images non-imaging data in patient context.
Catalog Number
45980163324X
Brand Name
Illumeo
Version/Model Number
v2.2
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
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
K173588
Product Code
LLZ
Product Code Name
System, image processing, radiological
Public Device Record Key
9ea7ec37-9ef3-46da-bb9b-33a7b5644ea2
Public Version Date
May 08, 2019
Public Version Number
1
DI Record Publish Date
April 30, 2019
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 349 |