Collimator, Manual, Radiographic
Regulation 892.1610
0510(k)s in 12 months (17 all time)
0recalls in 12 months (4 all time)
4recalls that name a 510(k)
Top companies in IZX
| Company | 510(k)s | Recalls |
|---|---|---|
| Summit Industries, Inc. | 1 | 3 |
| Shimadzu Corp. | 3 | 0 |
| Advantech | 2 | 0 |
| Applied X-Ray Technologies, Inc. | 1 | 0 |
| Bennett X-Ray Corp. | 1 | 0 |
| D&R X-Ray Products, Inc. | 1 | 0 |
| Dynarad Corp. | 1 | 0 |
| Emi Medical, Inc. | 1 | 0 |
| Instrumentarium Imaging, Inc. | 1 | 0 |
| Ito X-Ray Corp. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 8, 2012 | Shimadzu Medical Systems R-20J , Diagnostic X-Ray Beam-Limiting Device.
In combination with any of below X-Ray tubes:
06/1.2P364DK-85, 0.6/1.2P324DK-125,
06/1.2P324DK-85, 0.6/1.2P38DE-85.
Product Usage:
The device is the b Terminated |
IZX | K101036 |
| Aug 29, 2007 | Summit Industries Inc. PCS125 Swivel Collimator, Model F100; Manual Radiographic Collimator; Summit Industries, Inc., Chicago, Illinois Terminated |
IZX | K874687 |
| Aug 29, 2007 | Summit Industries Inc. LX125V Swivel Collimator, Model E600; Manual Radiographic Collimator; Summit Industries, Inc., Chicago, Illinois Terminated |
IZX | K874687 |
| Aug 29, 2007 | Summit Industries Inc. LX125 Swivel Collimator, Model D800; Manual Radiographic Collimator; Summit Industries, Inc., Chicago, Illinois Terminated |
IZX | K874687 |
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