FDA UDI
In Commercial Distribution
🇺🇸 United States
MAMMI
DI: 08437018413041
·
Model: MAMMI DR
·
GENERAL EQUIPMENT FOR MEDICAL IMAGING SA
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- MAMMI
- Primary DI
- 08437018413041
- Version / Model
- MAMMI DR
- Catalog Number
- FP-0203
- Company Name
- GENERAL EQUIPMENT FOR MEDICAL IMAGING SA
- Labeler DUNS
- 463337670
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-01-14
- Public Version
- 1
- Public Version Date
- 2022-01-24
- Public Version Status
- New
- Public Device Record Key
- 2b107f0e-3257-4d36-8495-bab49efb6741
Device Description
MAMMI is a Positron Emission Tomography (PET) system for medical imaging applications and for measuring the distribution of positron-emitting radiodrugs administered to patients to detect breast cancer. The system MAMMI presents two modalities: - Breast PET Mammography System with a single ring detector and a prone examination bed. - Breast PET Mammography System with a double ring detector and a prone examination bed (this record).
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- Yes
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- Yes
- 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 |
|---|---|---|---|---|
| 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 | 08437018413041 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K161631 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Height | 1480 | Millimeter | |
| Length | 1430 | Micrometer | |
| Width | 661 | Millimeter | |
| Weight | 160 | Kilogram |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -15 – 50 Degrees Celsius
- Type
- Handling Environment Temperature
- Temperature Range
- 10 – 40 Degrees Celsius
- Type
- Storage Environment Humidity
- Temperature Range
- 30 – 70 Percent (%) Relative Humidity
- Type
- Handling Environment Humidity
- Temperature Range
- 30 – 70 Percent (%) Relative Humidity