Data / Medical devices / United States / Standard Imaging, Inc.
Standard Imaging, Inc.: FDA-registered device maker in Middleton, WI, United States, 8 510(k) clearances
Standard Imaging, Inc. is registered with the FDA (registration 2184007) in Middleton, WI, United States. It lists 13 device types. The FDA files 8 510(k) clearances under its listings, the newest dated April 4, 2018. 1 recall event names it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 2184007
- FEI number
- 1000115748
- Address
- 3120 Deming Way, Middleton, WI, United States, 53562
- Owner or operator
- STANDARD IMAGING, INC. (9003193)
- Roles
- Contract manufacturer, Manufacturer, Repackager or relabeler
- First device listed
- June 24, 1992
- Registered through
- 2027
- Brand names listed
- Adaptivo, Blue Water, CT/SIM Check Phantom, DoseView 1D, DoseView 3D, Exradin Ion Chambers, Exradin Scanning Diodes, Exradin Scintillator Detectors and more
Devices it lists
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 |
|---|---|---|---|---|---|---|
| April 4, 2018 | K180595 | SciMoCa | IYE | Substantially Equivalent | Radialogica, LLC | accessdata.fda.gov |
| October 27, 2017 | K172534 | LINACwatch, LinacView | IYE | Substantially Equivalent | Qualiformed Sarl | accessdata.fda.gov |
| February 3, 2016 | K152994 | Adaptivo | IYE | Substantially Equivalent | Aurora Technology Development, LLC | accessdata.fda.gov |
| December 27, 2010 | K103193 | DOSEVIEW 3D | IYE | Substantially Equivalent | Standard Imaging, Inc. | accessdata.fda.gov |
| April 11, 2006 | K060532 | HDR 1000 PLUS WELL CHAMBER, MODEL 90008 | JAQ | Substantially Equivalent | Standard Imaging, Inc. | accessdata.fda.gov |
| November 15, 2004 | K042733 | STANDARD IMAGING PIPSPRO QA SOFTWARE SYSTEM | LHO | Substantially Equivalent | Standard Imaging, Inc. | accessdata.fda.gov |
| August 29, 2003 | K031975 | IMSURE | IYE | Substantially Equivalent | Prodigm, Inc. | accessdata.fda.gov |
| August 2, 2000 | K001825 | STANDARD IMAGING HDR 1000 PLUS ION CHAMBER; STANDARD IMAGING IVB 1000 ION CHAMBER | JAQ | Substantially Equivalent | Standard Imaging, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| May 28, 2003 | 26445 | Not yet classified | Terminated | Exradin A12 Ionization Chamber | Ionization chambers, used for checking x-ray equipment, were experiencing some drift from the tested calibration factors. | accessdata.fda.gov |
Compare with other makers
- All makers of Phantom, Anthropomorphic, Radiographic
- All makers of Accelerator, Linear, Medical
- All makers of Shield, Protective, Personnel
- All makers of Holder, Head, Radiographic
- All makers of Instrument, Quality-Assurance, Radiologic
- All makers of System, Applicator, Radionuclide, Remote-Controlled
Updated April 4, 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.