FDA Registration
Active
🇺🇸 United States
eVolve PACS
Reg #: 3025620599
·
FEI: 3025620599
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- SMAART MEDICAL SYSTEMS, INC.
- Registration Number
- 3025620599
- FEI Number
- 3025620599
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 14330 Midway Road, #118
- City
- Dallas
- State
- TX
- ZIP
- 75244
- Country
- US
Regulatory Submissions
- 510(k) Number
- K211863
Owner / Operator
- Firm Name
- SMAART Medical Systems, Inc.
- Operator Number
- 10086967
- Address
- 14330 Midway Road, #118
- City
- Dallas
- State
- TX
- Postal Code
- 75244
- Country
- US
- Correspondent
- Kim Terry
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Image Processing, Radiological | LLZ | Class 2 | Radiology | No | 2022-12-27 |
Proprietary Names
eVolve PACS
Establishment Types
Manufacture Medical Device