FDA UDI
In Commercial Distribution
🇺🇸 United States
SCINTRON
DI: 04260484140050
·
Model: SCINTRON
·
MiE medical imaging electronics GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- SCINTRON
- Primary DI
- 04260484140050
- Version / Model
- SCINTRON
- Company Name
- MiE medical imaging electronics GmbH
- Labeler DUNS
- 537604915
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-07-25
- Public Version
- 1
- Public Version Date
- 2018-08-27
- Public Version Status
- New
- Public Device Record Key
- 1c7632fe-c1e0-46c2-8ccf-431d2b6df073
Device Description
Gamma Camera Workstation for Acquisition, Reviewing and Processing
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
- Yes
- Has Lot/Batch Number
- No
- 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 |
|---|---|---|---|---|
| 40969 | Nuclear medicine system operator console, multi-purpose | A multi-purpose device that can be a component of a nuclear medicine (NM) imaging system, e.g., a single photon emission computed tomography (SPECT), positron emission tomography (PET) or a gamma camera and which functions as the primary control panel. It typically includes hardware and software that allows for image display, processing, analysis, archiving and retrieval. It typically includes the capabilities to be interfaced with a picture archiving and communication system (PACS), a local area network (LAN), a radiology information system (RIS) or a hospital information system (HIS). It contains the primary controls for the direct operation of the main system. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04260484140050 | GS1 |
Customer Contacts
- Phone
- +49419499770
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K101013 | 000 |