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.