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Xoran Workstation
XORAN TECHNOLOGIES LLC · Model v5.15.5 · UDI-DI 00860290000391
1
510(k) clearances
8
Adverse events
7
Recalls
48
Facilities
Description
Xoran Workstation is an image processing and viewing software for use with compatible radiographic data. The workstation software provides tools for image processing, viewing, interpretation, annotation, clinical review, analysis, distribution, archival, printing, and administrative reporting by healthcare professionals.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-08-26 | OSSTEM Implant Co., Ltd. | Osstem Implant Co. Ltd, is voluntarily initiating a medical device correction involving the current labeling for this electronic product may be missing a required Certification Sta |
| 2025-08-26 | OSSTEM Implant Co., Ltd. | Osstem Implant Co. Ltd, is voluntarily initiating a medical device correction involving the current labeling for this electronic product may be missing a required Certification Sta |
| 2025-08-26 | OSSTEM Implant Co., Ltd. | Osstem Implant Co. Ltd, is voluntarily initiating a medical device correction involving the current labeling for this electronic product may be missing a required Certification Sta |
| 2021-10-28 | Palodex Group Oy | It was noticed in production on 28.10.2021, that the final testing database gives a pass result for Pan ADC repeatability test even when the test result is not within the set accep |
| 2021-07-21 | Trophy SAS | Device failed to function as intended and/or failed to conform to their design specifications. |
| 2018-12-31 | KaVo Dental Technologies LLC | ORTHOPANTOMOGRAPH OP 3D device has a defect in the device firmware versions 2.1.0 and 2.1.1 |
| 2015-08-05 | Villa Radiology Systems LLC | It has been discovered that due to lack of information accompanying documents the product fails to comply with 21CfR 1020.33(c),1020.33(d),1020.33(g),and 1020.330). |
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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.