FDA Registration
Active
🇨🇦 Canada
IntelePACS
Reg #: 9615916
·
FEI: 3003768392
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- INTELERAD MEDICAL SYSTEMS INCORPORATED
- Registration Number
- 9615916
- FEI Number
- 3003768392
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 800, Boul. de Maisonneuve Est, 14th floor
- City
- MONTREAL Quebec
- Country
- CA
Regulatory Submissions
- 510(k) Number
- K192176
Owner / Operator
- Firm Name
- Intelerad Medical Systems Incorporated
- Operator Number
- 9040757
- Address
- 800, boul. de Maisonneuve Est, 14th floor
- City
- MONTREAL
- State
- Quebec
- Postal Code
- H2L 4L8
- Country
- CA
- Correspondent
- Karen Kazak
US Agent
- Business Name
- Intelerad Holdings USA Ltd.
- Contact Name
- Karen Kazak
- Address
- 305 Church At North Hills St Fl 6
- City
- Raleigh
- State
- NC
- ZIP
- 27609
- Country
- US
- [email protected]
- Phone
- 984 3081473
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Image Processing, Radiological | LLZ | Class 2 | Radiology | No | 2020-04-06 |
Proprietary Names
IntelePACS
Establishment Types
Manufacture Medical Device