FDA Registration
Active
🇺🇸 United States
CANDELIS, INC.
Reg #: 3005919188
·
FEI: 3005919188
·
Expires 2026
Products
1
Proprietary Names
3
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- CANDELIS, INC.
- Registration Number
- 3005919188
- FEI Number
- 3005919188
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 9903 South Santa Monica Blvd, #2101
- City
- Beverly Hills
- State
- CA
- ZIP
- 90212
- Country
- US
Regulatory Submissions
- 510(k) Number
- K111694
Owner / Operator
- Firm Name
- Candelis, Inc.
- Operator Number
- 9092139
- Address
- 9903 S Santa Monica Blvd. # 2101, --
- City
- Beverly Hills
- State
- CA
- Postal Code
- 90212
- Country
- US
- Correspondent
- Isabel Osorio
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Image Processing, Radiological | LLZ | Class 2 | Radiology | No | 2011-11-11 |
Proprietary Names
ASTRA
IMAGEGRID
IMAGEGRID RADIOLOGY VIEWER SYSTEM
Establishment Types
Manufacture Medical Device