FDA Registration
Active
🇺🇸 United States
BUNKERHILL HEALTH
Reg #: 3027245002
·
FEI: 3027245002
·
Expires 2026
Products
4
Proprietary Names
6
Establishment Types
1
Classifications
4
Registration Details
- Registration Name
- BUNKERHILL HEALTH
- Registration Number
- 3027245002
- FEI Number
- 3027245002
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 144 2nd St Ste 100
- City
- San Francisco
- State
- CA
- ZIP
- 94105
- Country
- US
Regulatory Submissions
- 510(k) Number
- K260167
Owner / Operator
- Firm Name
- Bunkerhill Health
- Operator Number
- 10087898
- Address
- 436 Bryant Street
- City
- San Francisco
- State
- CA
- Postal Code
- 94107
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, X-Ray, Tomography, Computed | JAK | Class 2 | Radiology | No | 2026-05-29 |
| Automated Radiological Image Processing Software | QIH | Class 2 | Radiology | No | 2026-05-29 |
| Reduced Ejection Fraction Machine Learning-Based Notification Software | QYE | Class 2 | Cardiovascular | No | 2026-05-29 |
| Densitometer, Bone | KGI | Class 2 | Radiology | No | 2026-05-29 |
Proprietary Names
Bunkerhill Contrast AVC
iCAC Device
Bunkerhill Abdominal Aortic Quantification (AAQ)
Bunkerhill ECG-EF
BunkerHill BMD
CAC (gated)
Establishment Types
Manufacture Medical Device