FDA UDI
In Commercial Distribution
🇺🇸 United States
DELTAmanager
DI: 00861333000309
·
Model: 12
·
MEDIMAGE, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- DELTAmanager
- Primary DI
- 00861333000309
- Version / Model
- 12
- Company Name
- MEDIMAGE, INC.
- Labeler DUNS
- 147197602
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-14
- Public Version
- 5
- Public Version Date
- 2023-01-10
- Public Version Status
- Update
- Public Device Record Key
- 825eb7e9-a8bb-42f7-a277-a830902dc838
Device Description
DELTAmanager is a software package that provides display, review, and communications for Nuclear Medicine, Molecular Imaging, and PET/CT images. DELTAmanager may be used for remote reading on a stand alone workstation or as a plug-in on a PACS workstation.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- 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 |
|---|---|---|---|---|
| KPS | System, Tomography, Computed, Emission | Radiology | 892.1200 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60724 | Multidisciplinary medical image management software | A software application intended to be used to receive, collect, store, and display a broad range of medical imaging and/or video data, and to distribute the data within or between healthcare facilities to facilitate data analysis, organization, reporting, and sharing (e.g., teaching); it might be designed for holographic viewing of three-dimensional (3-D) images in conjunction with an appropriate headset or for real-time communication of diagnostic/surgical images, and might also enable the control of light settings of a device (e.g., microscope) for image acquisition. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00861333000309 | GS1 |
Customer Contacts
- Phone
- 734-665-5400
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K933321 | 000 |