FDA UDI
In Commercial Distribution
🇺🇸 United States
BIOGRAPH One
DI: 04068151020472
·
Model: 11689172
·
Siemens Healthineers AG
Product Codes
5
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- BIOGRAPH One
- Primary DI
- 04068151020472
- Version / Model
- 11689172
- Company Name
- Siemens Healthineers AG
- Labeler DUNS
- 314699460
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-01-20
- Public Version
- 1
- Public Version Date
- 2026-01-28
- Public Version Status
- New
- Public Device Record Key
- b9fa753a-8696-46d4-ab34-44ff87b9b106
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 |
|---|---|---|---|---|
| MOS | Coil, magnetic resonance, specialty | Radiology | 892.1000 | 2 |
| LNH | System, nuclear magnetic resonance imaging | Radiology | 892.1000 | 2 |
| OUO | Tomographic imager combining emission computed tomography with nuclear magnetic resonance | Radiology | 892.1200 | 2 |
| KPS | System, tomography, computed, emission | Radiology | 892.1200 | 2 |
| LNI | System, nuclear magnetic resonance spectroscopic | Radiology | 892.1000 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58250 | PET/MRI system | A diagnostic radiological imaging system that is a combination of a positron emission tomography (PET) camera system for nuclear medicine (NM) images, and a magnetic resonance imaging (MRI) system for magnetic resonance images. The nuclear medicine images and the magnetic resonance images may be registered and displayed in a fused format (overlaid in the same orientation) for the anatomical localization of the nuclear medicine data (i.e., distribution of radiopharmaceuticals). The PET and MRI portions of the system may be used independently or in combination; their images may be transferred to other systems for additional processing. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04068151020472 | GS1 |
Customer Contacts
- Phone
- +1(800)888-7436
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K253023 | 000 |