FDA Registration
Active
🇺🇸 United States
Affirm Breast Biopsy Guidance System
Reg #: 3005496266
·
FEI: 3005496266
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- HOLOGIC, INC.
- Registration Number
- 3005496266
- FEI Number
- 3005496266
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 600 Technology Drive
- City
- Newark
- State
- DE
- ZIP
- 19702
- Country
- US
Regulatory Submissions
- 510(k) Number
- K122836
Owner / Operator
- Firm Name
- HOLOGIC, INC.
- Operator Number
- 9007676
- Address
- 250 Campus Drive, --
- City
- Marlborough
- State
- MA
- Postal Code
- 01752
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, X-Ray, Mammographic | IZH | Class 2 | Radiology | No | 2013-09-03 |
Proprietary Names
Affirm Breast Biopsy Guidance System
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device