Data / Medical devices / United States / Huestis Machine Corp.
Huestis Machine Corp.: FDA-registered device maker in Bristol, RI, United States, 11 510(k) clearances
Huestis Machine Corp. is registered with the FDA (registration 1219183) in Bristol, RI, United States. It lists 13 device types. The FDA files 11 510(k) clearances under its listings, the newest dated September 14, 2018. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1219183
- Address
- 68 Buttonwood ST., Bristol, RI, United States, 02809
- Owner or operator
- HUESTIS MACHINE CORP. (1219183)
- Roles
- Complaint file establishment, Manufacturer, Manufacturer for export
- First device listed
- February 13, 1978
- Registered through
- 2026
- Brand names listed
- ACCUBOOST APPLICATOR, ACCUBOOST DIGITAL POSITIONING ACCESSORY; ACCUBOOST POSITIONING ACCESSORY, ACCUVISION, HUESTIS COMPU-CUTTER AND PO, HUESTIS COMPU-FORMER AN, HUESTIS FLEXI-HOLDER, Huestis Centralite Patient Positioning Laser, Huestis Collimator and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accelerator, Linear, Medical | IYE | 2 | Manufacturer | accessdata.fda.gov |
| Block, Beam-Shaping, Radiation Therapy | IXI | 2 | Manufacturer | accessdata.fda.gov |
| Cassette, Radiographic Film | IXA | 2 | Manufacturer | accessdata.fda.gov |
| Collimator, Manual, Radiographic | IZX | 2 | Manufacturer | accessdata.fda.gov |
| Cradle, Patient, Radiologic | KXH | 1 | Manufacturer | accessdata.fda.gov |
| Monitor, Patient Position, Light-Beam | IWE | 1 | Manufacturer | accessdata.fda.gov |
| Shield, Protective, Personnel | KPY | 1 | Manufacturer | accessdata.fda.gov |
| Solid State X-Ray Imager (Flat Panel/Digital Imager) | MQB | 2 | Complaint file establishment | accessdata.fda.gov |
| System, Applicator, Radionuclide, Manual | IWJ | 1 | Manufacturer | accessdata.fda.gov |
| System, Applicator, Radionuclide, Remote-Controlled | JAQ | 2 | Manufacturer | accessdata.fda.gov |
| System, Simulation, Radiation Therapy | KPQ | 2 | Manufacturer for export | accessdata.fda.gov |
| System, Therapeutic, X-Ray | JAD | 2 | Manufacturer | accessdata.fda.gov |
| System, X-Ray, Mobile | IZL | 2 | Complaint file establishment | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| September 14, 2018 | K181874 | MX40 Mobile Digital X-ray System | IZL | Substantially Equivalent | Huestis Machine Corporation | accessdata.fda.gov |
| November 7, 2006 | K062135 | ART SHIELDED BREAST APPLICATOR | JAQ | Substantially Equivalent | Advanced Radiation Therapy, LLC | accessdata.fda.gov |
| March 17, 1999 | K981153 | OSIRIS | IYE | Substantially Equivalent | Huestis Medical | accessdata.fda.gov |
| August 21, 1997 | K972966 | AXT 150M MANUAL COLLIMATOR (AXT 150M) | IZX | Substantially Equivalent | Applied X-Ray Technologies, Inc. | accessdata.fda.gov |
| January 24, 1995 | K940145 | COMPU-CUTTER THERAPEUTIC SHIELDING CUTTING DEVICE | IYE | Substantially Equivalent | Huestis Machine Corp. | accessdata.fda.gov |
| April 15, 1994 | K926187 | POSICAST IMMOBILIZATION SYSTEM | IYE | Substantially Equivalent | Huestis Machine Corp. | accessdata.fda.gov |
| November 29, 1990 | K904005 | HUESTIS FLEXI-BOARD | JAD | Substantially Equivalent | Huestis Machine Corp. | accessdata.fda.gov |
| May 31, 1990 | K901567 | THE HUESTIS COMPU-PLOTTER | IXI | Substantially Equivalent | Huestis Machine Corp. | accessdata.fda.gov |
| April 11, 1988 | K880047 | HUESTIS COMPU-FORMER | IXI | Substantially Equivalent | Huestis Machine Corp. | accessdata.fda.gov |
| October 14, 1986 | K863890 | MAMM-AIRE | KXH | Substantially Equivalent | Ar Custom Medical Products, Ltd. | accessdata.fda.gov |
| February 19, 1980 | K792721 | HUESTIS FLEXI-HOLDER | IXA | Substantially Equivalent | Huestis Machine Corp. | accessdata.fda.gov |
Compare with other makers
- All makers of Accelerator, Linear, Medical
- All makers of Block, Beam-Shaping, Radiation Therapy
- All makers of System, X-Ray, Mobile
- All makers of Solid State X-Ray Imager (Flat Panel/Digital Imager)
- All makers of System, Simulation, Radiation Therapy
- All makers of Collimator, Manual, Radiographic
Updated September 14, 2018. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.