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Dicom Box
HYLAND LLC · Model 1 · UDI-DI 00850677007037
1
510(k) clearances
5
Adverse events
2
Recalls
8
Facilities
Description
Dicom Box Image Acquisition Unit
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2019-09-25 | Brainlab AG | The Brainlab Patient Data Manager software (PDM) in combination with the Brainlab iPlan CMF/Cranial/ENT/Spine software 2.1.1, 2.2.0, 2.2.1, 2.3.0, 2.3.1, 2.4.0, 2.5.0, 2.5.1 (if us |
| 2005-03-30 | Konica Medical Imaging, Inc. | One feature of the software on some of the devices which permits assembling three digital images into one image has occasionally had problems aligning the three images exactly. |
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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.