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 | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LLZ | System, image processing, radiological | Radiology | 892.2050 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 41670 | Radiological PACS software | An individual software application intended to be installed on a central server as part of a picture archiving and communication system (PACS) to allow storage, retrieval, analysis, and management of radiological images. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00884838100350 | GS1 |
Customer Contacts
- Phone
- +1(999)999-9999
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K170580 | 000 |