FDA Registration
Active
🇺🇸 United States
Galaxy RTi
Reg #: 3015621321
·
FEI: 3015621321
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
3
Classifications
1
Registration Details
- Registration Name
- Akesis Inc.
- Registration Number
- 3015621321
- FEI Number
- 3015621321
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 5129 Commercial Circle
- City
- Concord
- State
- CA
- ZIP
- 94520
- Country
- US
Regulatory Submissions
- 510(k) Number
- K203146
Owner / Operator
- Firm Name
- Akesis Inc
- Operator Number
- 10088577
- Address
- 5129 Commercial Circle
- City
- Concord
- State
- CA
- Postal Code
- 94520
- Country
- US
- Correspondent
- Lien Pham
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Radiation Therapy, Radionuclide | IWB | Class 2 | Radiology | No | 2023-08-18 |
Proprietary Names
Galaxy RTi
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device