FDA UDI
In Commercial Distribution
🇺🇸 United States
ANCORIS
DI: 04260484140067
·
Model: ANCORIS
·
MiE medical imaging electronics GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- ANCORIS
- Primary DI
- 04260484140067
- Version / Model
- ANCORIS
- 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
- 2021-06-11
- Public Version
- 1
- Public Version Date
- 2021-06-21
- Public Version Status
- New
- Public Device Record Key
- 2f4fde6e-5382-4aed-8aeb-199dc2fd306f
Device Description
The ‘ANCORIS’ PET Scanner is designed to acquire data, process and display images by appropriated trained medical professionals via measuring the distribution of injected positron emitting radiopharmaceuticals in humans for the purpose of determining various metabolic and physiologic functions within the human body.
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 |
|---|---|---|---|---|
| 40644 | PET system | An assembly of devices comprising a diagnostic, positron emission tomography (PET) imaging system used to detect, record, quantify and analyse 511 kilo-electronvolt (keV) photon emission patterns resulting from annihilation reactions produced during the decay of positron emitting radiopharmaceuticals. It produces three-dimensional (3-D) tomographic digital cross-sectional physiological images representing distribution patterns of positron emitting radiopharmaceuticals ingested by, or injected into the patient. It typically uses lead collimators and specialized software for image reconstruction allowing mapping of metabolic patterns and rates associated with targeted physiological processes. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04260484140067 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K201807 | 000 |