FDA Registration
Active
🇺🇸 United States
Hoffman 2-D Brain Phantom (BR/2D/P)
Reg #: 3002989475
·
FEI: 3002989475
·
Expires 2025
Products
1
Proprietary Names
13
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- DATA SPECTRUM CORP.
- Registration Number
- 3002989475
- FEI Number
- 3002989475
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 1605 E CLUB BLVD
- City
- DURHAM
- State
- NC
- ZIP
- 27704
- Country
- US
Owner / Operator
- Firm Name
- DATA SPECTRUM CORPORATION
- Operator Number
- 9092367
- Address
- 1605 E Club Blvd
- City
- Durham
- State
- NC
- Postal Code
- 27704
- Country
- US
- Correspondent
- JOHN JASZCZAK
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Phantom, Anthropomorphic, Nuclear | IYP | Class 1 | Radiology | No | 2006-09-15 |
Proprietary Names
Hoffman 2-D Brain Phantom (BR/2D/P)
3D Brain Phantom Solid Defect Set (2) (BR/3D-SOL/SET2)
Cardiac Insert with Fillable Defect Set (ECT/CAR/I)
Hoffman Multi-Compartment 2-D Brain Phantom (BR/2D-MC/P)
Anthropomorphic Torso Phantom (ECT/TOR/P)
Medium Solid Breast Phantom (ECT/SOL-BR/MED)
Elliptical Lung-Spine Phantom Lid (ECT/LUNG/I)
Dynamic Cardiac Phantom (ECT/DY-CAR/P)
Large Solid Breast Phantom (ECT/SOL-BR/LG)
Hoffman 3-D Brain Phantom (BR/3D/P)
Fillable Spine Insert (ECT/FIL-SPINE/I)
Elliptical Lung-Spine Body Phantom (ECT/LUNG/P)
Body Contour Rings (3) (ECT/BCR/SET3)
Establishment Types
Manufacture Medical Device