HUESTIS MACHINE CORP.

FDA Device Registration & Listing · Bristol, RI, US · Registration 1219183

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
1219183
FEI Number
1219183
Entity Name
HUESTIS MACHINE CORP.
City/State/Country
Bristol, RI, US
Establishment Address
68 BUTTONWOOD ST., Bristol, RI 02809, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
HUESTIS MACHINE CORP. (Owner Number: 1219183)
Owner / Operator Contact Address
68 BUTTONWOOD ST., --, Bristol, RI 02809, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K062135
PMA Number
N/A

All Registered 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

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
IXI Block, Beam-Shaping, Radiation Therapy Radiology Class 2 892.5710 2010-05-11
IZX Collimator, Manual, Radiographic Radiology Class 2 892.1610 2010-05-11
KPY Shield, Protective, Personnel Radiology Class 1 892.6500 1978-02-13
IZL System, X-Ray, Mobile Radiology Class 2 892.1720 2019-03-13
MQB Solid State X-Ray Imager (Flat Panel/Digital Imager) Radiology Class 2 892.1680 2019-03-13
IYE Accelerator, Linear, Medical Radiology Class 2 892.5050 2010-05-11
IXI Block, Beam-Shaping, Radiation Therapy Radiology Class 2 892.5710 2005-08-15
IYE Accelerator, Linear, Medical Radiology Class 2 892.5050 2005-08-15
KPQ System, Simulation, Radiation Therapy Radiology Class 2 892.5840 2014-04-29
JAQ System, Applicator, Radionuclide, Remote-Controlled Radiology Class 2 892.5700 2023-07-18

Official Correspondent

Frederick Correira

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

HUESTIS MACHINE CORP.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K153059 Minxray, Inc. HF1202H PowerPlus Portable X-ray Equipment 2016-02-02
K070563 Vidar Systems Corp. VIDAR VISION 2000 2007-03-16
K190691 Pixxgen Corporation Pixx2430 Digital Diagnostic X-Ray Receptor Panel 2019-04-04
K150150 Rayence Co., Ltd. 1717SGN / 1717SCN Digital Flat Panel X-ray Detector 2015-03-27
K140771 Philips Medical Systems Dmc GmbH PHILIPS ELEVA WORKSPOT 2014-04-25

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-1470-2023 FUJIFILM Healthcare Americas Corporation 2
FujiFilm FDR AQRO (Model DR-XD1000)- A digital mobile X-ray system intended for use in general purpose radiography for generating radiographic images of human anatomy, including adult, pediatric, and neonatal exams
Z-3158-2024 FUJIFILM Healthcare Americas Corporation 2
The device is a mobile x-ray system designed to work with Fujifilm's GOS and CsI scintillator FDR D-EVO2 (DR-ID) 12XXSE) family of digital x-ray detectors coupled.
Z-0005-2009 Toshiba American Medical Systems Inc 2
Toshiba Infinix fluoroscopy DFP-8000D Digital Radiography System with version 3.40 or higher software. Controller for Infinix interventional angiography systems.
Z-0031-2007 AGFA Corp. 2
CR DX-S, Image Intensified Fluoroscopic X-ray system.
Z-0004-2019 Varian Medical Systems 2
TrueBeam Radiotherapy Delivery System version 2.0 and 2.5 EDGE Radiotherapy Delivery System version 2.0 and 2.5 Product Usage: The TrueBeam delivery systems are intended to provide radiotherapy and stereotactic radiosurgery for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1219183. Last updated year: 2026. Please use registration number 1219183 when referencing this establishment in official correspondence.
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