FDA Registration
Active
🇺🇸 United States
Exo Imaging, Inc.
Reg #: 3017487805
·
FEI: 3017487805
·
Expires 2026
Products
5
Proprietary Names
2
Establishment Types
2
Classifications
5
Registration Details
- Registration Name
- Exo Imaging, Inc.
- Registration Number
- 3017487805
- FEI Number
- 3017487805
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 4201 Burton Drive
- City
- Santa Clara
- State
- CA
- ZIP
- 95054
- Country
- US
Regulatory Submissions
- 510(k) Number
- K222198
Owner / Operator
- Firm Name
- Exo Imaging
- Operator Number
- 10085070
- Address
- 4201 Burton Drive
- City
- Santa Clara
- State
- CA
- Postal Code
- 95054
- Country
- US
- Correspondent
- Mugdha Dongre
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Digital Image Communications, Radiological | LMD | Class 1 | Radiology | No | 2022-05-02 |
| Transducer, Ultrasonic, Diagnostic | ITX | Class 2 | Radiology | No | 2023-12-19 |
| System, Imaging, Pulsed Echo, Ultrasonic | IYO | Class 2 | Radiology | No | 2023-12-19 |
| System, Imaging, Pulsed Doppler, Ultrasonic | IYN | Class 2 | Radiology | No | 2023-12-19 |
| Automated Radiological Image Processing Software | QIH | Class 2 | Radiology | No | 2025-01-23 |
Proprietary Names
Exo Works Enterprise/ Exo Works Connect
Exo Iris
Establishment Types
Manufacture Medical Device
Develop Specifications But Do Not Manufacture At This Facility