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510(k) Data Aggregation
K Number
K192936Device Name
Soltus 500
Manufacturer
Date Cleared
2019-11-15
(28 days)
Regulation Number
892.1720Why did this record match?
Applicant Name (Manufacturer) :
Sedecal., SA.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. Not for mammography
Device Description
The Soltus 500 Mobile Digital X-Ray System, Model 10501, ("Mobile X-Ray System") is the same as the predicate mobile PhoeniX with 2 additional features, (i) Distributed Antenna System (DAS), and (ii) Enhanced Work Flow (EWF). The Mobile X-Ray System has motorized movement and full battery operation. It contains a touch screen that operates as a control console. The Mobile X-Ray System supports various Canon flat panel detectors (Digital Radiography CXDI) supplied with the unit.
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