Collimator, Automatic, Radiographic
Regulation 892.1610
0510(k)s in 12 months (23 all time)
0recalls in 12 months (3 all time)
2recalls that name a 510(k)
Top companies in IZW
| Company | 510(k)s | Recalls |
|---|---|---|
| Ralco S.R.L. | 3 | 0 |
| Shimadzu Medical Systems | 2 | 1 |
| Omega Medical Imaging, Inc. | 2 | 0 |
| Philips Medical Systems, Inc. | 2 | 0 |
| Philips Medical Systems North America Co. Phillips | 0 | 2 |
| Shimadzu Corp. | 2 | 0 |
| Collimare, LLC | 1 | 0 |
| D&R X-Ray Products, Inc. | 1 | 0 |
| Dealers X-Ray Co., Inc. | 1 | 0 |
| GE Medical Systems | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 8, 2012 | Shimadzu Medical Systems R-30H , Diagnostic X-Ray Beam-Limiting Device.
In combination with any of below X-ray tubes
0.6/1.2P364DK-85, 0.6/1.2P324DK-125,
0.6/1.2P324DK-85, 0.6/1.2P38DE-85
Device Model # R-30H.
Subsequent Terminated |
IZW | K090578 |
| Sep 16, 2008 | Philips Medical Systems North America Co. Phillips Philips Gallileo Automatic Collimator, Part Numbers: 9896 010 00612, 9896 010 00614, 9896 010 00615. The device is a diagnostic x-ray beam-limiting device intended to restrict the dimensions of a dia Terminated |
IZW | K951372 |
| Jun 14, 2007 | Philips Medical Systems North America Co. Phillips Philips Collimators, Model numbers: 9896 010 00614, 9896 010 00615, 9804 607 00301, and 9804 602 83501. Product is a Collimator/ Beam Limiting Device and are replacement components for the Bucky Diag Terminated |
IZW | None listed |
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