FDA Registration
Active
🇺🇸 United States
OPTIS Mobile System
Reg #: 3009600098
·
FEI: 3009600098
·
Expires 2025
Products
1
Proprietary Names
4
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- Abbott Medical
- Registration Number
- 3009600098
- FEI Number
- 3009600098
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 4 Robbins Rd
- City
- Westford
- State
- MA
- ZIP
- 01886
- Country
- US
Regulatory Submissions
- 510(k) Number
- K232386
Owner / Operator
- Firm Name
- ABBOTT LABORATORIES
- Operator Number
- 1415939
- Address
- 100 ABBOTT PARK RD., D-03Q3, AP52-1
- City
- Abbott Park
- State
- IL
- Postal Code
- 60064
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Imaging, Optical Coherence Tomography (Oct) | NQQ | Class 2 | Radiology | No | 2023-09-26 |
Proprietary Names
OPTIS Mobile System
AptiVue Imaging Software version E.6
OPTIS Integrated System
ILUMIEN OPTIS System
Establishment Types
Manufacture Medical Device
Develop Specifications But Do Not Manufacture At This Facility