FDA Registration
Active
🇺🇸 United States
HUESTIS MACHINE CORP.
Reg #: 1219183
·
FEI: 1219183
·
Expires 2026
Products
13
Proprietary Names
16
Establishment Types
3
Classifications
13
Registration Details
- Registration Name
- HUESTIS MACHINE CORP.
- Registration Number
- 1219183
- FEI Number
- 1219183
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 68 BUTTONWOOD ST.
- City
- Bristol
- State
- RI
- ZIP
- 02809
- Country
- US
Regulatory Submissions
- 510(k) Number
- K901567
Owner / Operator
- Firm Name
- HUESTIS MACHINE CORP.
- Operator Number
- 1219183
- Address
- 68 BUTTONWOOD ST., --
- City
- Bristol
- State
- RI
- Postal Code
- 02809
- Country
- US
- Correspondent
- Frederick M Correira
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Block, Beam-Shaping, Radiation Therapy | IXI | Class 2 | Radiology | No | 2010-05-11 |
| Collimator, Manual, Radiographic | IZX | Class 2 | Radiology | No | 2010-05-11 |
| Shield, Protective, Personnel | KPY | Class 1 | Radiology | No | 1978-02-13 |
| System, X-Ray, Mobile | IZL | Class 2 | Radiology | No | 2019-03-13 |
| Solid State X-Ray Imager (Flat Panel/Digital Imager) | MQB | Class 2 | Radiology | No | 2019-03-13 |
| Accelerator, Linear, Medical | IYE | Class 2 | Radiology | No | 2010-05-11 |
| System, Simulation, Radiation Therapy | KPQ | Class 2 | Radiology | No | 2014-04-29 |
| System, Applicator, Radionuclide, Remote-Controlled | JAQ | Class 2 | Radiology | No | 2023-07-18 |
| System, Applicator, Radionuclide, Manual | IWJ | Class 1 | Radiology | No | 2023-07-18 |
| System, Therapeutic, X-Ray | JAD | Class 2 | Radiology | No | 2010-05-11 |
| Monitor, Patient Position, Light-Beam | IWE | Class 1 | Radiology | No | 2021-02-01 |
| Cassette, Radiographic Film | IXA | Class 2 | Radiology | No | 2005-08-15 |
| Cradle, Patient, Radiologic | KXH | Class 1 | Radiology | No | 2023-10-24 |
Proprietary Names
Huestis Compu-Plotter
Huestis Collimator
TISSUE COMPENSATION ATT
STYRO-FORMER
MX40 Mobile Digital X-Ray System
Osiris
HUESTIS COMPU-FORMER AN
HUESTIS COMPU-CUTTER AND PO
Huestis Medical-Cascade Simulator
ACCUBOOST APPLICATOR
ACCUBOOST DIGITAL POSITIONING ACCESSORY; ACCUBOOST POSITIONING ACCESSORY
Posicast Immobilization System
Huestis Flexi-Board
Huestis Centralite Patient Positioning Laser
HUESTIS FLEXI-HOLDER
ACCUVISION
Establishment Types
Manufacture Medical Device
Complaint File Establishment per 21 CFR 820.198
Manufacture Device in the United States for Export Only