FDA Registration
Active
🇺🇸 United States
SCIMAGE, INC.
Reg #: 2952596
·
FEI: 3000206530
·
Expires 2026
Products
4
Proprietary Names
2
Establishment Types
3
Classifications
4
Registration Details
- Registration Name
- SCIMAGE, INC.
- Registration Number
- 2952596
- FEI Number
- 3000206530
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 4916 EL CAMINO REAL, SUITE 200
- City
- LOS ALTOS
- State
- CA
- ZIP
- 94022
- Country
- US
Regulatory Submissions
- 510(k) Number
- K170032
Owner / Operator
- Firm Name
- SCIMAGE, INC.
- Operator Number
- 9026453
- Address
- 4916 EL CAMINO REAL, SUITE 200, --
- City
- Los Altos
- State
- CA
- Postal Code
- 94022
- Country
- US
- Correspondent
- MADVI RAYA
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Computer, Diagnostic, Programmable | DQK | Class 2 | Cardiovascular | No | 2022-04-07 |
| Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | MWI | Class 2 | Cardiovascular | No | 2022-04-07 |
| System, Image Processing, Radiological | LLZ | Class 2 | Radiology | No | 2010-01-15 |
| System, Digital Image Communications, Radiological | LMD | Class 1 | Radiology | No | 1996-06-13 |
Proprietary Names
Netra Workstation and NetraMD Software
PicomEnterprise
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Repack or Relabel Medical Device
Manufacture Medical Device