DOSEVIEW 3D
STANDARD IMAGING, INC.
STANDARD IMAGING, INC.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 2184007 | 1000115748 | STANDARD IMAGING, INC. | 1 | N | 2026-01-01 | 3120 DEMING WAY MIDDLETON WI US 53562 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 44107 | 1076250720 | K180595 | SciMoCa | IYE | 2018-04-04 |
| 44107 | 1024682843 | K172534 | LINACwatch, LinacView | IYE | 2017-10-27 |
| 44107 | 1086826773 | K152994 | Adaptivo | IYE | 2016-02-03 |
| 44107 | 1662743226 | K103193 | DOSEVIEW 3D | IYE | 2010-12-27 |
| 44107 | 1412397573 | K060532 | HDR 1000 PLUS WELL CHAMBER, MODEL 90008 | JAQ | 2006-04-11 |
| 44107 | 2000921344 | K042733 | STANDARD IMAGING PIPSPRO QA SOFTWARE SYSTEM | LHO | 2004-11-15 |
| 44107 | 2014647627 | K040688 | STANDARD IMAGING E.IMRT CALCULATOR | MUJ | 2004-05-11 |
| 44107 | 1364798495 | K031975 | IMSURE | IYE | 2003-08-29 |
| 44107 | 1318096709 | K001825 | STANDARD IMAGING HDR 1000 PLUS ION CHAMBER; STANDARD IMAGING IVB 1000 ION CHAMBER | JAQ | 2000-08-02 |
| 44107 | 1252193336 | ||||
| 44107 | 1790410709 | ||||
| 44107 | 2054346353 | ||||
| 44107 | 1112930578 | ||||
| 44107 | 1136250811 | ||||
| 44107 | 1142644968 | ||||
| 44107 | 1312005188 | ||||
| 44107 | 1847031840 |
Product Codes Associated With Registrations#
PMN#
STANDARD IMAGING IMSURE BRACHY QA SOFTWARE, MODEL 91331
STANDARD IMAGING, INC.
HDR 1000 PLUS WELL CHAMBER, MODEL 90008
STANDARD IMAGING, INC.
STANDARD IMAGING PIPSPRO QA SOFTWARE SYSTEM
STANDARD IMAGING, INC.
STANDARD IMAGING E.IMRT CALCULATOR
STANDARD IMAGING, INC.
STANDARD IMAGING IVB 1000 WELL CHAMBER
STANDARD IMAGING, INC.
MODIFICATION TO STANDARD IMAGING PT 1000 ION CHAMBER
STANDARD IMAGING, INC.
STANDARD IMAGING HDR 1000 PLUS ION CHAMBER; STANDARD IMAGING IVB 1000 ION CHAMBER
STANDARD IMAGING, INC.
STAND IMAGING DOSE CALIBRATOR SHIELDED WORK PLATFORM
STANDARD IMAGING, INC.
STANDARD IMAGING HDR 1000 ION CHAMBER
STANDARD IMAGING, INC.
GUDID#
Standard Imaging IMSure 3D - Standard Imaging IMSure 3D (IM3D) QA software is intended to be used for radiation dose calculation and radiation treatment plan quality assurance in radiation therapy.
2023-11-29
Standard Imaging Seed Slider - Standard Imaging Seed Slider is designed for loading LDR Brachytherapy seeds and spacers into prostate needles.
2023-06-22
Standard Imaging Needle Loading Shield - Standard Imaging Needle Loading Shield provide a convenient work station for counting and handling seeds and for loading into needles in a radiation shielded environment.
2023-06-22
Standard Imaging Needle Cradle - Standard Imaging Needle Cradle is designed for storage of loaded LDR prostate implant needles, prior to use in a patient.
2023-06-22
Standard Imaging CDX 2000B Electrometer - Standard Imaging CDX 2000B Electrometer is a portable electrometer designed to be connected to a radiation detector, (ionization chamber, well chamber, or diode detector), and measure the electrical current produced by the detector during irradiation.
2023-06-22
Standard Imaging MAX 4000 Plus Electrometer - Standard Imaging MAX 4000 Plus Electrometer is a portable electrometer designed to be connected to a radiation detector, (ionization chamber, well chamber, or diode detector), and measure the electrical current produced by the detector during irradiation.
2023-06-22
Standard Imaging SuperMAX Electrometer - Standard Imaging SuperMAX Electrometer is a 2-channel electrometer designed to be connected to a radiation detector, (ionization chamber, well chamber, diode, or scintillator detector), and measure the electrical current produced by the detector during irradiation.
2023-06-22
Standard Imaging MAX SD - Standard Imaging MAX SD is a high end optical signal processing electrometer designed for use with Exradin W2 scintillation detectors. The MAX SD provides functionality for traditional point dose measurements and it can be used as a field detector in a scanning water tank.
2023-06-22
Standard Imaging QA BeamChecker Plus - Standard Imaging QA BeamChecker Plus is a reliable and uncomplicated measurement instrument for daily quality assurance testing of linear accelerator, TomoTherapy Hi Art System, or other rotational delivery treatment machine output.
2023-06-22
Standard Imaging QA StereoChecker - Standard Imaging QA StereoChecker is a daily machine quality assurance checks for the Cyberknife (Accuray, Sunnyvale CA).
2023-06-22
Standard Imaging Exradin Magna 600 - Standard Imaging Exradin Magna 600 is a medical device intended for absolute dose measurement for radiation (therapeutic, diagnostic, nuclear and/or environmental).
2023-06-22
Standard Imaging Exradin Magna 650 Ion Chamber - Standard Imaging Exradin Magna 650 is a medical device intended for absolute dose measurement for radiation (therapeutic, diagnostic, nuclear and/or environmental).
2023-06-22
Standard Imaging Exradin A17 Ion Chamber - Standard Imaging Exradin A17 is a medical device intended for absolute dose measurement for radiation (therapeutic, diagnostic, nuclear and/or environmental).
2023-06-22
Standard Imaging Exradin A101 Ion Chamber - Standard Imaging Exradin A101 is a medical device intended for absolute dose measurement for radiation (therapeutic, diagnostic, nuclear and/or environmental).
2023-06-22
Standard Imaging Exradin A12 Ion Chamber - Standard Imaging Exradin A12 is a medical device intended for absolute dose measurement for radiation (therapeutic, diagnostic, nuclear and/or environmental).
2023-06-22
Standard Imaging Exradin A11 Ion Chamber - Standard Imaging Exradin A11 is a medical device intended for absolute dose measurement for radiation (therapeutic, diagnostic, nuclear and/or environmental).
2023-06-22
Standard Imaging Exradin A1 Ion Chamber - Standard Imaging Exradin A1 is a medical device intended for absolute dose measurement for radiation (therapeutic, diagnostic, nuclear and/or environmental).
2023-06-22
Standard Imaging Exradin A11TW Ion Chamber - Standard Imaging Exradin A11TW is a medical device intended for absolute dose measurement for radiation (therapeutic, diagnostic, nuclear and/or environmental).
2023-06-22
Standard Imaging Exradin A14 Ion Chamber - Standard Imaging Exradin A14 is a medical device intended for absolute dose measurement for radiation (therapeutic, diagnostic, nuclear and/or environmental).
2023-06-22
Standard Imaging TomoElectrometer - Standard Imaging TomoElectrometer is a 8-channel electrometer designed to be connected to a radiation detector, (ionization chamber, well chamber, or diode detector), and measure the electrical current produced by the detector during irradiation.
2023-06-22
Standard Imaging Exradin A4 Ion Chamber - Standard Imaging Exradin A4 is a medical device intended for absolute dose measurement for radiation (therapeutic, diagnostic, nuclear and/or environmental).
2023-06-22
Standard Imaging Exradin A6 Ion Chamber - Standard Imaging Exradin A6 is a medical device intended for absolute dose measurement for radiation (therapeutic, diagnostic, nuclear and/or environmental).
2023-06-22
Standard Imaging Exradin A3 Ion Chamber - Standard Imaging Exradin A3 is a medical device intended for absolute dose measurement for radiation (therapeutic, diagnostic, nuclear and/or environmental).
2023-06-22
Standard Imaging DoseView 1D - Standard Imaging DoseView 1D fulfills the requirements set forth by the AAPM TG-51 Protocol for a single dimension water scanning phantom. Determining the depth-dose curve and Source to Axis Distance (SAD) measurements are easily done with the system.
2023-06-22
Standard Imaging Exradin T2 Ion Chamber with Gas Flow - Standard Imaging Exradin T2 Ion Chamber with Gas Flow is a medical device intended for absolute dose measurement for radiation (therapeutic, diagnostic, nuclear and/or environmental).
2023-06-22
Standard Imaging Exradin A1SL Ion Chamber - Standard Imaging Exradin A1SL is a medical device intended for absolute dose measurement for radiation (therapeutic, diagnostic, nuclear and/or environmental).
2023-06-22
Standard Imaging Exradin A14SL Ion Chamber - Standard Imaging Exradin A14SL is a medical device intended for absolute dose measurement for radiation (therapeutic, diagnostic, nuclear and/or environmental).
2023-06-22
Standard Imaging Exradin A5 Ion Chamber - Standard Imaging Exradin A5 is a medical device intended for absolute dose measurement for radiation (therapeutic, diagnostic, nuclear and/or environmental).
2023-06-22
Standard Imaging Exradin A12S Ion Chamber - Standard Imaging Exradin A12S is a medical device intended for absolute dose measurement for radiation (therapeutic, diagnostic, nuclear and/or environmental).
2023-06-22
Standard Imaging Exradin A16 Ion Chamber - Standard Imaging Exradin A16 is a medical device intended for absolute dose measurement for radiation (therapeutic, diagnostic, nuclear and/or environmental).
2023-06-22
Standard Imaging Exradin A18 Ion Chamber - Standard Imaging Exradin A18 is a medical device intended for absolute dose measurement for radiation (therapeutic, diagnostic, nuclear and/or environmental).
2023-06-22
Standard Imaging Exradin A19 Ion Chamber - Standard Imaging Exradin A19 is a medical device intended for absolute dose measurement for radiation (therapeutic, diagnostic, nuclear and/or environmental).
2023-06-22
Standard Imaging Exradin A20 Ion Chamber - Standard Imaging Exradin A20 is a medical device intended for absolute dose measurement for radiation (therapeutic, diagnostic, nuclear and/or environmental).
2023-06-22
Standard Imaging Exradin A8 Ion Chamber - Standard Imaging Exradin A8 is a medical device intended for absolute dose measurement for radiation (therapeutic, diagnostic, nuclear and/or environmental).
2023-06-22
Standard Imaging Exradin M2 Ion Chamber with Gas Flow - Standard Imaging Exradin M2 Ion Chamber with Gas Flow is a medical device intended for absolute dose measurement for radiation (therapeutic, diagnostic, nuclear and/or environmental).
2023-06-22
Standard Imaging Exradin A26 Ion Chamber - Standard Imaging Exradin A26 is a medical device intended for absolute dose measurement for radiation (therapeutic, diagnostic, nuclear and/or environmental).
2023-06-22
Standard Imaging Exradin A28 Ion Chamber - Standard Imaging Exradin A28 is a medical device intended for absolute dose measurement for radiation (therapeutic, diagnostic, nuclear and/or environmental).
2023-06-22
Standard Imaging Exradin A1SLMR Ion Chamber - Standard Imaging Exradin A1SLMR is a medical device intended for absolute dose measurement for radiation (therapeutic, diagnostic, nuclear and/or environmental).
2023-06-22
Standard Imaging Exradin A26MR Ion Chamber - Standard Imaging Exradin A26MR is a medical device intended for absolute dose measurement for radiation (therapeutic, diagnostic, nuclear and/or environmental).
2023-06-22
Standard Imaging Exradin A28MR Ion Chamber - Standard Imaging Exradin A28MR is a medical device intended for absolute dose measurement for radiation (therapeutic, diagnostic, nuclear and/or environmental).
2023-06-22