STANDARD IMAGING, INC.

FDA Device Registration & Listing · MIDDLETON, WI, US · Registration 2184007

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
2184007
FEI Number
1000115748
Entity Name
STANDARD IMAGING, INC.
City/State/Country
MIDDLETON, WI, US
Establishment Address
3120 DEMING WAY, MIDDLETON, WI 53562, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
STANDARD IMAGING, INC. (Owner Number: 9003193)
Owner / Operator Contact Address
3120 DEMING WAY, --, Middleton, WI 53562, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K060532
PMA Number
N/A

All Registered Proprietary Names

IMSure Brachy IMSure QA TomoScanner Exradin Scintillator Detectors QA BeamChecker Plus QA StereoChecker Mammo Compression Tool MAX Elite MAX 4000 Plus Exradin Scanning Diodes SuperMAX Exradin Ion Chambers QA BeamChecker Pro CT/SIM Check Phantom MAX SD Luthmann Source QA Tool DoseView 1D TomoElectrometer HDR 1000 Plus Well Chamber IVB 1000 Well Chamber Radiation Analyzer Film Dosimetry Software QA Pilot IMSure 3D PIPSPro Software, LinacView Adaptivo Blue Water MIMI Phantom Virtual Water Reconstruction Jig RGP Phantom LUCY 3D QA Phantom IonQA Phantom Stereotactic Dose Verification Phantom IMRT Phantom LUCY EA Phantom Winston Lutz Cube Phantom IMRT Dose Verification Phantom LUCY MR Phantom ThorX Phantom ISOCube Phantom TomoPhantom Gafchromic™ QuiCk Phantom™ MIMI MR Phantom TG-142 Phantom MR Grid Phantom DoseView 3D TomoScanner 3D Multiple Needle Loading Shields HDR 1000 Plus with Xoft Insert

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
IYE Accelerator, Linear, Medical Radiology Class 2 892.5050 2007-10-15
LHO Instrument, Quality-Assurance, Radiologic Radiology Class 1 892.1940 1992-06-24
JAQ System, Applicator, Radionuclide, Remote-Controlled Radiology Class 2 892.5700 2007-10-15
IWJ System, Applicator, Radionuclide, Manual Radiology Class 1 892.5650 2007-10-15
MWW Accessory - Film Dosimetry System Radiology Class 2 892.5050 2020-01-02
OUG Medical Device Data System General Hospital Class 1 880.6310 2015-03-11
IYE Accelerator, Linear, Medical Radiology Class 2 892.5050 2022-10-26
IXG Phantom, Anthropomorphic, Radiographic Radiology Class 1 892.1950 2007-10-15
LMB Device, Digital Image Storage, Radiological Radiology Class 1 892.2010 2007-10-15
LHO Instrument, Quality-Assurance, Radiologic Radiology Class 1 892.1940 2007-10-15
LMD System, Digital Image Communications, Radiological Radiology Class 1 892.2020 2007-10-15
LLZ System, Image Processing, Radiological Radiology Class 2 892.2050 2007-10-15
IYE Accelerator, Linear, Medical Radiology Class 2 892.5050 2007-10-15
IYE Accelerator, Linear, Medical Radiology Class 2 892.5050 2023-04-26
IYE Accelerator, Linear, Medical Radiology Class 2 892.5050 2023-06-15
IXG Phantom, Anthropomorphic, Radiographic Radiology Class 1 892.1950 2001-06-12
IYE Accelerator, Linear, Medical Radiology Class 2 892.5050 2015-05-13
IWY Holder, Head, Radiographic Radiology Class 1 892.1920 2022-10-26
KPY Shield, Protective, Personnel Radiology Class 1 892.6500 1996-03-22
KXK Source, Brachytherapy, Radionuclide Radiology Class 2 892.5730 2007-10-15
JAQ System, Applicator, Radionuclide, Remote-Controlled Radiology Class 2 892.5700 2007-10-15

Official Correspondent

Ellen Young

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

STANDARD IMAGING, INC.
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
K071992 Varian Medical Systems HIGH-DEFINITION 120 MULTILEAF COLLIMATOR (HD120 MLC) 2007-08-15
K253962 Radformation, Inc. ClearCheck (RADCC V2.7) 2026-04-03
K003779 Arplay Medical S.A. IMMOBILIZATION SYSTEM FOR ENT 2001-07-12
K973037 Avid N.I.T., Inc. N.I.T., INC. RADIONUCLIDE SEED APPLICATOR, MODEL SA-1000 1998-01-27
K080013 Agfa Healthcare Corporation REGISTRATION AND FUSION 2008-01-17

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
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.
Z-0005-2019 Varian Medical Systems 2
VitalBeam Radiotherapy Delivery System Version 2.5 Product Usage: The VitalBeam delivery systems are intended to provide precision radiotherapy and stereotactic radiosurgery for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.
Z-0020-2015 N/A 2
Proteus 235 Proton Therapy System for cancer treatment.
Z-0035-2012 Accuray Incorporated 2
CyberKnife Robotic Radiosurgery System, Synchrony Respiratory Tracking System (Standard Treatment Couch). Synchrony Respiratory Tracking System, a Radiation Therapy Device, Model Numbers: 026429, 028185. Product is manufactured and distributed by Accuray, Inc., Sunnyvale, CA
Z-0036-2012 Accuray Incorporated 2
CyberKnife Robotic Radiosurgery System, Synchrony Respiratory Tracking System (Robocouch Patient Positioning System), a Radiation Therapy Device. Model Numbers: 026430, 028186. Product is manufactured and distributed by Accuray, Inc., Sunnyvale, CA

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2184007. Last updated year: 2026. Please use registration number 2184007 when referencing this establishment in official correspondence.
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