FDA Registration
Active
🇦🇺 Australia
IQ - UIP
Reg #: 3017426576
·
FEI: 3017426576
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- 4DMEDICAL LIMITED
- Registration Number
- 3017426576
- FEI Number
- 3017426576
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Level 7 Melbourne Connect, 700 Swanston Street
- City
- Carlton Victoria
- Country
- AU
Regulatory Submissions
- 510(k) Number
- K242467
Owner / Operator
- Firm Name
- 4DMedical Limited
- Operator Number
- 10077775
- Address
- Level 7,, 700 Swanston street
- City
- Carlton
- State
- Victoria
- Postal Code
- 3053
- Country
- AU
US Agent
- Business Name
- 4DMedical
- Contact Name
- Andreas Fouras
- Address
- 21255 Burbank Blvd, Suite 120
- City
- Woodland Hills
- State
- CA
- ZIP
- 91367
- Country
- US
- [email protected]
- Phone
- 818 4031151
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Radiology Software For Referral Of Findings Related To Fibrotic Lung Disease. | QWO | Class 2 | Radiology | No | 2025-02-06 |
Proprietary Names
IQ - UIP
Establishment Types
Manufacture Medical Device