FDA Registration
Active
🇺🇸 United States
Continuum PACS
Reg #: 3016735536
·
FEI: 3016735536
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- INTEGRATED OPHTHALMIC SYSTEMS, INC.
- Registration Number
- 3016735536
- FEI Number
- 3016735536
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 596 Main Street
- City
- Woburn
- State
- MA
- ZIP
- 01801
- Country
- US
Regulatory Submissions
- 510(k) Number
- K200385
Owner / Operator
- Firm Name
- Integrated Ophthalmic Systems, Inc.
- Operator Number
- 10069477
- Address
- 596 Main Street
- City
- Woburn
- State
- MA
- Postal Code
- 01801
- Country
- US
- Correspondent
- Matthew Carnevale
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Image Management, Ophthalmic | NFJ | Class 2 | Radiology | No | 2020-04-13 |
Proprietary Names
Continuum PACS
Establishment Types
Manufacture Medical Device