FDA Registration
Active
🇦🇺 Australia
Imaging Solutions (AU)
Reg #: 3009222501
·
FEI: 3009222501
·
Expires 2026
Products
4
Proprietary Names
9
Establishment Types
3
Classifications
4
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Registration Details
- Registration Name
- Imaging Solutions (AU)
- Registration Number
- 3009222501
- FEI Number
- 3009222501
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 30-36 Relentless Court
- City
- Park Ridge Queensland
- Country
- AU
Owner / Operator
- Firm Name
- Imaging Solutions Pty Ltd
- Operator Number
- 10072261
- Address
- 30-36 Relentless Court
- City
- Park Ridge
- State
- Queensland
- Postal Code
- 4125
- Country
- AU
US Agent
- Business Name
- Imaging Solutions of America Inc
- Contact Name
- Ben Honey
- Address
- 222 W Las Colinas Blvd., Suite 1650E
- City
- Irving
- State
- TX
- ZIP
- 75039
- Country
- US
- [email protected]
- Phone
- 469 7887220
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Stretcher, Wheeled | FPO | Class 2 | General Hospital | No | 2020-09-16 |
| Shield, Protective, Personnel | KPY | Class 1 | Radiology | No | 2020-07-23 |
| Apron, Protective | IWO | Class 1 | Radiology | No | 2020-04-29 |
| Radiographic Protective Glove | IWP | Class 1 | Radiology | No | 2021-08-24 |
Proprietary Names
Imaging Solutions MR Fixed Height Stretcher
Imaging Solutions MR Adjustable Height Stretcher
Imaging Solutions MR Economy Stretcher
RADsafe
RADshield
RADdrape
Radionex
RadSafe
RadGlove
Establishment Types
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)
Export Device to the United States But Perform No Other Operation on Device