FDA Registration
Active
🇺🇸 United States
18L5s
Reg #: 2532090
·
FEI: 3003408255
·
Expires 2025
Products
4
Proprietary Names
26
Establishment Types
1
Classifications
4
Registration Details
- Registration Name
- SOUND TECHNOLOGY INC.
- Registration Number
- 2532090
- FEI Number
- 3003408255
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 401 Science Park Road
- City
- STATE COLLEGE
- State
- PA
- ZIP
- 16803
- Country
- US
Regulatory Submissions
- 510(k) Number
- K231764
Owner / Operator
- Firm Name
- GE HealthCare Technologies Inc.
- Operator Number
- 9912004
- Address
- 3000 N. Grandview Blvd
- City
- Waukesha
- State
- WI
- Postal Code
- 53188
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Transducer, Ultrasonic, Diagnostic | ITX | Class 2 | Radiology | No | 2023-11-08 |
| System, Imaging, Pulsed Echo, Ultrasonic | IYO | Class 2 | Radiology | No | 2023-11-08 |
| Automated Radiological Image Processing Software | QIH | Class 2 | Radiology | No | 2023-11-08 |
| System, Imaging, Pulsed Doppler, Ultrasonic | IYN | Class 2 | Radiology | No | 2023-11-08 |
Proprietary Names
18L5s
E14C4t
6C2
X12C4
X14L4
5C1e
20R3
5P1e
6C2s
I14C5I
14L3e
E10C4
E13C2
E11C3b
N11C5s
E14CL4b
9c2
13L4w
8L2
I14C5T
Ultrasound System 1300
I12C5b
X18L5s
N13C5
14L3
18L5
Establishment Types
Manufacture Medical Device