Standard Imaging Inc.
Middleton, WI, US
STANDARD IMAGING, INC. appears in FDA device records in Middleton, WI. FDA records list 10 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show one recall for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 10 510(k) clearances for Standard Imaging Inc. between 1992 and 2010. The busiest year on record is 2000, with 2. The most recent is 2010, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1992 | 1 |
| 1994 | 1 |
| 2000 | 2 |
| 2001 | 1 |
| 2004 | 2 |
| 2006 | 1 |
| 2008 | 1 |
| 2010 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K103193 | DOSEVIEW 3D | IYE | Substantially Equivalent | |
| K082773 | STANDARD IMAGING IMSURE BRACHY QA SOFTWARE, MODEL 91331 | IYE | Substantially Equivalent | |
| K060532 | HDR 1000 PLUS WELL CHAMBER, MODEL 90008 | JAQ | Substantially Equivalent | |
| K042733 | STANDARD IMAGING PIPSPRO QA SOFTWARE SYSTEM | LHO | Substantially Equivalent | |
| K040688 | STANDARD IMAGING E.IMRT CALCULATOR | MUJ | Substantially Equivalent | |
| K013548 | STANDARD IMAGING IVB 1000 WELL CHAMBER | KPT | Substantially Equivalent | |
| K002833 | MODIFICATION TO STANDARD IMAGING PT 1000 ION CHAMBER | KPT | Substantially Equivalent | |
| K001825 | STANDARD IMAGING HDR 1000 PLUS ION CHAMBER; STANDARD IMAGING IVB 1000 ION CHAMBER | JAQ | Substantially Equivalent | |
| K940539 | STAND IMAGING DOSE CALIBRATOR SHIELDED WORK PLATFORM | KPY | Substantially Equivalent | |
| K922554 | STANDARD IMAGING HDR 1000 ION CHAMBER | JAQ | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 2184007 | 1000115748 | STANDARD IMAGING, INC. | 3120 DEMING WAY, MIDDLETON, WI 53562 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
- MWWAccessory - Film Dosimetry System
- KPTCalibrator, Dose, Radionuclide
- LMBDevice, Digital Image Storage, Radiological
- IWYHolder, Head, Radiographic
- LHOInstrument, Quality-Assurance, Radiologic
- OUGMedical Device Data System
- IXGPhantom, Anthropomorphic, Radiographic
- KPYShield, Protective, Personnel
- KXKSource, Brachytherapy, Radionuclide
- IWJSystem, Applicator, Radionuclide, Manual
- JAQSystem, Applicator, Radionuclide, Remote-Controlled
- LMDSystem, Digital Image Communications, Radiological
- LLZSystem, Image Processing, Radiological
- MUJSystem, Planning, Radiation Therapy Treatment
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0952-03 | Exradin A12 Ionization Chamber | Ionization chambers, used for checking x-ray equipment, were experiencing some drift from the tested calibration factors. | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain