FDA UDI
In Commercial Distribution
🇺🇸 United States
Advantis Platform
DI: 05214002307035
·
Model: 4
·
ADVANTIS MEDICAL IMAGING SINGLE MEMBER P.C.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Advantis Platform
- Primary DI
- 05214002307035
- Version / Model
- 4
- Company Name
- ADVANTIS MEDICAL IMAGING SINGLE MEMBER P.C.
- Labeler DUNS
- 523550273
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-01-24
- Public Version
- 1
- Public Version Date
- 2024-02-01
- Public Version Status
- New
- Public Device Record Key
- 24d4edc9-2481-4abc-a9a2-408e40fdf18a
Device Description
Advantis Platform is a web-accessible medical viewing and post-processing software application. Advantis Platform offers comprehensive functionality for dynamic image analysis and visualization of brain and prostate MRI data which are acquired through DICOM-compliant imaging devices and modalities.
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
- No
- 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 |
|---|---|---|---|---|
| 57812 | Radiology DICOM image processing application software | A software application intended to facilitate management, distribution, and/or viewing of radiological digital imaging and communications in medicine (DICOM) image data; it is not intended for pathological image interpretation (i.e., not intended to detect and localize suspected abnormalities). It may be intended to facilitate image management (e.g., viewing, communication, printing, recording/disc burning) and/or image quality manipulation and quantification (e.g., non-interpretive graphical overlays). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05214002307035 | GS1 |
Customer Contacts
- Phone
- +302109329558
- [email protected]