FDA Registration
Active
🇺🇸 United States
MEDICATECH USA
Reg #: 3004989804
·
FEI: 3004989804
·
Expires 2026
Products
4
Proprietary Names
18
Establishment Types
3
Classifications
4
Registration Details
- Registration Name
- MEDICATECH USA
- Registration Number
- 3004989804
- FEI Number
- 3004989804
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 1245 N Patt St
- City
- Anaheim
- State
- CA
- ZIP
- 92801
- Country
- US
Regulatory Submissions
- 510(k) Number
- K190601
Owner / Operator
- Firm Name
- Medicatech USA
- Operator Number
- 9073041
- Address
- 1245 N Patt Street
- City
- Anaheim
- State
- CA
- Postal Code
- 92801
- Country
- US
- Correspondent
- George Makar
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Generator, High-Voltage, X-Ray, Diagnostic | IZO | Class 1 | Radiology | No | 2025-04-30 |
| Device, Digital Image Storage, Radiological | LMB | Class 1 | Radiology | No | 2025-04-11 |
| System, X-Ray, Stationary | KPR | Class 2 | Radiology | No | 2020-07-13 |
| Solid State X-Ray Imager (Flat Panel/Digital Imager) | MQB | Class 2 | Radiology | No | 2020-07-13 |
Proprietary Names
NexGen 940 Series
NexGen 900 Series
NexGen 960 Series
NexGen 950 Series
MasteRad® MX PACS
MasteRad MX30
MAK1100
KrystalRad1100
MasteRad® MX40
MasterX 800 Series
MasterX802C
MasterX802G
MasterX804Ce
MasterX803G
MasterX801G
MasterX803C
MasterX801C
KrystaRad 1100
Establishment Types
Repack or Relabel Medical Device
Manufacture Medical Device
Develop Specifications But Do Not Manufacture At This Facility