FDA Registration
Active
🇺🇸 United States
VOMARK TECHNOLOGIES INC
Reg #: 3014639846
·
FEI: 3014639846
·
Expires 2026
Products
4
Proprietary Names
3
Establishment Types
2
Classifications
4
Registration Details
- Registration Name
- VOMARK TECHNOLOGIES INC
- Registration Number
- 3014639846
- FEI Number
- 3014639846
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 406 Diens Dr
- City
- Wheeling
- State
- IL
- ZIP
- 60090
- Country
- US
Regulatory Submissions
- 510(k) Number
- K141093
Owner / Operator
- Firm Name
- Vomark Technologies Inc
- Operator Number
- 10062568
- Address
- 406 Diens Dr
- City
- Wheeling
- State
- IL
- Postal Code
- 60090
- Country
- US
- Correspondent
- Volodymyr Markevych
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Transducer, Ultrasonic, Diagnostic | ITX | Class 2 | Radiology | No | 2025-02-26 |
| System, Imaging, Pulsed Doppler, Ultrasonic | IYN | Class 2 | Radiology | No | 2025-04-14 |
| System, Imaging, Pulsed Echo, Ultrasonic | IYO | Class 2 | Radiology | No | 2025-04-14 |
| System, Image Processing, Radiological | LLZ | Class 2 | Radiology | No | 2025-07-30 |
Proprietary Names
12L-RS; 12S-RS; 3Sc-RS; 4C-RS; 6S-RS; 6Tc-RS; 6VT-D; 8C-RS; 9L-RS; 9T-RS; C1-5-RS; E8Cs-RS; L8-18i-RS; M5Sc-RS; ML6-15-
GE Invenia ABUS Viewer
Toshiba Aplio
Establishment Types
Repack or Relabel Medical Device
Remanufacture Medical Device