FDA UDI
In Commercial Distribution
🇺🇸 United States
IntelliSpace Portal
DI: 00884838083646
·
Model: 6.5
·
Philips Medical Systems Nederland B.V.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- IntelliSpace Portal
- Primary DI
- 00884838083646
- Version / Model
- 6.5
- 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
- 2016-09-24
- Public Version
- 4
- Public Version Date
- 2023-09-26
- Public Version Status
- Update
- Public Device Record Key
- 15c94a34-7d1a-4444-bd03-eec8dde485d3
Device Description
The IntelliSpace Portal V6.5 processes clinical images from a SBI* series that was generated by Philips IQon system and enables advanced visualization of the images. When used by qualified personnel, it provides useful diagnostic information. IntelliSpace Portal V6.5 can be used remotely by multiple users with compatible devices *SBI: Spectral Base Images. A set of dataset that are being used as the inputs for calculation of Spectral results that are being used for reading.
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 |
|---|---|---|---|---|
| 36572 | CT system workstation | A device that is a component of a computed tomography (CT) system and which is designed to receive and transmit data both on-line and off-line. It is typically located at a site remote from the operator's console. It differs from the operator console in that it does not contain the controls for the direct operation of the CT system. It is configured to provide the capability to further process, manipulate and/or view patient images and information collected from the CT system and possibly other related x-ray based imaging systems. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00884838083646 | GS1 |
Customer Contacts
- Phone
- +1(800)722-9377
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K150665 | 000 |