FDA Registration
Active
🇺🇸 United States
AKTINA MEDICAL CORP.
Reg #: 2436865
·
FEI: 1000521490
·
Expires 2026
Products
7
Proprietary Names
16
Establishment Types
1
Classifications
7
Registration Details
- Registration Name
- AKTINA MEDICAL CORP.
- Registration Number
- 2436865
- FEI Number
- 1000521490
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 360 N Route 9w
- City
- Congers
- State
- NY
- ZIP
- 10920
- Country
- US
Regulatory Submissions
- 510(k) Number
- K974239
Owner / Operator
- Firm Name
- AKTINA MEDICAL CORP.
- Operator Number
- 9011840
- Address
- 360 NORTH ROUTE 9W, --
- City
- Congers
- State
- NY
- Postal Code
- 10920
- Country
- US
- Correspondent
- TONY - SPACCAROTELLA
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Block, Beam-Shaping, Radiation Therapy | IXI | Class 2 | Radiology | No | 2007-11-06 |
| Monitor, Patient Position, Light-Beam | IWE | Class 1 | Radiology | No | 2003-07-22 |
| Couch, Radiation Therapy, Powered | JAI | Class 2 | Radiology | No | 2007-11-06 |
| Accelerator, Linear, Medical | IYE | Class 2 | Radiology | No | 2007-11-06 |
| Film, Radiographic | IWZ | Class 1 | Radiology | No | 2004-09-08 |
| Instrument, Quality-Assurance, Radiologic | LHO | Class 1 | Radiology | No | 2024-02-02 |
| Holder, Radiographic Cassette, Wall-Mounted | IXY | Class 1 | Radiology | No | 2003-07-22 |
Proprietary Names
Photon Beam Shaping Block
RETICLES AND GRATICULES
Tennis Racquet Insert
Tilt Board
Electron Beam Shaping System
Thermoplastic Mask
Carbon Fiber Table Top
PINPOINT STEREOTACTIC HEAD AND NECK LOCALIZER (Aktina Mouthpiece)
AKTINA FILMS
Radiation Therapy Wedges
Active Breathing Coordinator
UNIVERSAL CASSETTE HOLDERS
Circular Small Field Collimators, Elekta Integrated
Beam Block Tray
Protos Software
Frontpointer
Establishment Types
Manufacture Medical Device