FDA UDI In Commercial Distribution 🇺🇸 United States

Vue PACS (Diagnostic)

DI: 00884838100350 · Model: 12 · Philips Medical Systems Nederland B.V.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Vue PACS (Diagnostic)
Primary DI
00884838100350
Version / Model
12
Catalog Number
1149418
Company Name
Philips Medical Systems Nederland B.V.
Labeler DUNS
413819707
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2020-05-18
Public Version
3
Public Version Date
2023-10-18
Public Version Status
Update
Public Device Record Key
f8058edb-ddb8-467c-85bf-2ba1efcd6986

Device Description

The Vue PACS diagnostic client is web deployable and has a variety of user profiles applicable to different stakeholder in the cycle of care such as radiologists, referring physicians, technologists etc. With advanced streaming technology, the Vue PACS diagnostic client can perform well even over slow communication lines between the client and the server. Enterprise workflow capabilities allow users across the network to read and report from a global worklist, irrespective of the image acquisition location. The Vue Diagnostic workstation includes native clinical applications such as Lesion Management, CT Perfusion, MR Perfusion/Diffusion.

Device Characteristics

Single Use
No
Prescription Use (Rx)
Yes
Over the Counter (OTC)
No
Kit
No
Combination Product
No
HCT/P
No
Contains NRL
No
Not Made with NRL
No
MRI Safety
Labeling does not contain MRI Safety Information
Direct Marking Exempt
No
PM Exempt
No
Has Serial Number
No
Has Lot/Batch Number
Yes
Has Manufacturing Date
Yes
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
LLZ System, image processing, radiological

GMDN Terms

Code Name
41670 Radiological PACS software

Identifiers

Type ID
Primary 00884838100350

Customer Contacts

Premarket Submissions

Submission Number Supplement Number
K170580 000