FDA UDI
In Commercial Distribution
🇺🇸 United States
AnyScan
DI: 05999884132172
·
Model: AnyScan S
·
MEDISO Kft.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- AnyScan
- Primary DI
- 05999884132172
- Version / Model
- AnyScan S
- Company Name
- MEDISO Kft.
- Labeler DUNS
- 401469804
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-23
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- eb69c3b7-ad0f-4d43-be6c-cd675780a12c
Device Description
SPECT Imaging System
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
- Yes
- Has Lot/Batch Number
- No
- 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 |
|---|---|---|---|---|
| KPS | System, Tomography, Computed, Emission | Radiology | 892.1200 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 40642 | SPECT system, rotating detector head | An assembly of devices comprising a diagnostic, stationary, single photon emission computed tomography (SPECT) system that is a three-dimensional (3-D) tomographic imaging gamma camera-based system used to detect, record, quantify and analyse radionuclide emissions (primarily gamma rays) produced during the decay of radiopharmaceuticals or other radiation emitting materials injected into, or ingested by, a patient. The gantry is designed to rotate a collimated detector head or heads around the body in a pre-programmed motion sequence. The gantry position is typically fixed and the table moveable. The imaging capabilities of most SPECT systems include both static and dynamic imaging. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05999884132172 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K131625 | 000 |