FDA Registration
Active
🇺🇸 United States
Iris AirShuttle (TM)
Reg #: 2247992
·
FEI: 1000208827
·
Expires 2025
Products
10
Proprietary Names
1
Establishment Types
1
Classifications
10
Registration Details
- Registration Name
- Anholt Technologies Inc.
- Registration Number
- 2247992
- FEI Number
- 1000208827
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 440 CHURCH ROAD
- City
- Avondale
- State
- PA
- ZIP
- 19311
- Country
- US
Regulatory Submissions
- 510(k) Number
- K230312
Owner / Operator
- Firm Name
- Medtec LLC
- Operator Number
- 9033077
- Address
- 1401 8TH ST., S.E., --
- City
- Orange City
- State
- IA
- Postal Code
- 51041
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Radiation Therapy, Charged-Particle, Medical | LHN | Class 2 | Radiology | No | 2023-04-05 |
| System, X-Ray, Angiographic | IZI | Class 2 | Radiology | No | 2023-04-05 |
| Couch, Radiation Therapy, Powered | JAI | Class 2 | Radiology | No | 2023-04-05 |
| System, Tomography, Computed, Emission | KPS | Class 2 | Radiology | No | 2023-04-05 |
| System, Nuclear Magnetic Resonance Imaging | LNH | Class 2 | Radiology | No | 2023-04-05 |
| Accelerator, Linear, Medical | IYE | Class 2 | Radiology | No | 2023-04-05 |
| Interventional Fluoroscopic X-Ray System | OWB | Class 2 | Radiology | No | 2023-04-05 |
| Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance | OUO | Class 2 | Radiology | No | 2023-04-05 |
| Device, Patient Transfer, Powered | FRZ | Class 2 | General Hospital | No | 2023-04-05 |
| System, X-Ray, Tomography, Computed | JAK | Class 2 | Radiology | No | 2023-04-05 |
Proprietary Names
Iris AirShuttle (TM)
Establishment Types
Manufacture Medical Device