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Claymount
Varex Imaging Nederland B.V. · Model 50250-12-OEM · UDI-DI 08718755000306
IZX
Prescription
10
510(k) clearances
5
Adverse events
4
Recalls
13
Facilities
Description
x-ray beam-limiting device, to restrict the dimensions of a diagnostic x-ray field by limiting the size of the primary x-ray beam.(Collimator) This is a device of the Optica 20 series.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2011-10-28 | Shimadzu Medical Systems | Shimadzu is recalling Diagnostic X-ray Beam-Limiting Device, Mobile x-ray system and Diagnostic x-ray tube assembly because they do not comply with the Product Performance Standard |
| 2007-08-10 | Summit Industries Inc. | The D800 Swivel Collimator may come loose from the tubestand and fall onto the x-ray table. |
| 2007-08-10 | Summit Industries Inc. | The E600 Swivel Collimator may come loose from the tubestand and fall onto the x-ray table. |
| 2007-08-10 | Summit Industries Inc. | The F100 Swivel Collimator may come loose from the tubestand and fall onto the x-ray table. |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.