Huestis Machine Corp.
Bristol, RI, US
HUESTIS MACHINE CORP. appears in FDA device records in Bristol, RI. FDA records list 7 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 7 510(k) clearances for Huestis Machine Corp. between 1980 and 2018. The busiest year on record is 1990, with 2. The most recent is 2018, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1980 | 1 |
| 1988 | 1 |
| 1990 | 2 |
| 1994 | 1 |
| 1995 | 1 |
| 2018 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K181874 | MX40 Mobile Digital X-ray System | IZL | Substantially Equivalent | |
| K940145 | COMPU-CUTTER THERAPEUTIC SHIELDING CUTTING DEVICE | IYE | Substantially Equivalent | |
| K926187 | POSICAST IMMOBILIZATION SYSTEM | IYE | Substantially Equivalent | |
| K904005 | HUESTIS FLEXI-BOARD | JAD | Substantially Equivalent | |
| K901567 | THE HUESTIS COMPU-PLOTTER | IXI | Substantially Equivalent | |
| K880047 | HUESTIS COMPU-FORMER | IXI | Substantially Equivalent | |
| K792721 | HUESTIS FLEXI-HOLDER | IXA | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1219183 | 1219183 | HUESTIS MACHINE CORP. | 68 BUTTONWOOD ST., Bristol, RI 02809 US | 2026 | and 3 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- IYEAccelerator, Linear, Medical
- IXIBlock, Beam-Shaping, Radiation Therapy
- IXACassette, Radiographic Film
- IZXCollimator, Manual, Radiographic
- KXHCradle, Patient, Radiologic
- IWEMonitor, Patient Position, Light-Beam
- KPYShield, Protective, Personnel
- MQBSolid State X-Ray Imager (Flat Panel/Digital Imager)
- IWJSystem, Applicator, Radionuclide, Manual
- JAQSystem, Applicator, Radionuclide, Remote-Controlled
- KPQSystem, Simulation, Radiation Therapy
- JADSystem, Therapeutic, X-Ray
- IZLSystem, X-Ray, Mobile
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain