Company ยท US
Standard Imaging, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1992 to 2010. Name variants (Inc, Corp, punctuation) are merged.
10510(k) clearances (0 in 12 months)
1recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 27, 2010 | K103193 | DOSEVIEW 3D Standard Imaging, Inc. | IYE |
| Nov 19, 2008 | K082773 | STANDARD IMAGING IMSURE BRACHY QA SOFTWARE, MODEL 91331 Standard Imaging, Inc. | IYE |
| Apr 11, 2006 | K060532 | HDR 1000 PLUS WELL CHAMBER, MODEL 90008 Standard Imaging, Inc. | JAQ |
| Nov 15, 2004 | K042733 | STANDARD IMAGING PIPSPRO QA SOFTWARE SYSTEM Standard Imaging, Inc. | LHO |
| May 11, 2004 | K040688 | STANDARD IMAGING E.IMRT CALCULATOR Standard Imaging, Inc. | MUJ |
| Nov 9, 2001 | K013548 | STANDARD IMAGING IVB 1000 WELL CHAMBER Standard Imaging, Inc. | KPT |
| Sep 28, 2000 | K002833 | MODIFICATION TO STANDARD IMAGING PT 1000 ION CHAMBER Standard Imaging, Inc. | KPT |
| Aug 2, 2000 | K001825 | STANDARD IMAGING HDR 1000 PLUS ION CHAMBER; STANDARD IMAGING IVB 1000 ION CHAMBER Standard Imaging, Inc. | JAQ |
| Mar 16, 1994 | K940539 | STAND IMAGING DOSE CALIBRATOR SHIELDED WORK PLATFORM Standard Imaging, Inc. | KPY |
| Aug 24, 1992 | K922554 | STANDARD IMAGING HDR 1000 ION CHAMBER Standard Imaging, Inc. | JAQ |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 27, 2003 | Standard Imaging Inc. Exradin A12 Ionization Chamber Terminated |
IYE | None listed |