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510(k) Data Aggregation
K Number
K213691Device Name
Solas OR
Manufacturer
Cirdan Imaging Ltd
Date Cleared
2021-12-22
(29 days)
Product Code
MWP
Regulation Number
892.1680Why did this record match?
Applicant Name (Manufacturer) :
Cirdan Imaging Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Solas OR is a cabinet X-ray system used to provide digital X-ray images of surgical and core biopsy specimens from various anatomical regions in order to allow rapid verification that the correct tissue has been excised during the biopsy procedure.
Doing the verification in the same room as the procedure or nearby improves workflow, the time the patient needs to be under examination.
Device Description
The Solas OR cabinet x-ray system is a self-contained, direct-detection digital imaging system for imaging small to medium surgical and biopsy specimens. The system is comprised of the x-ray cabinet, optional cart and the PC with DICOM compliant software which provides the user interface, the means to enter patient details (either directly or from a DICOM Modality Worklist, if available) and the means to acquire, review and save or transmit DICOM images to the Picture Archiving and Communication System (PACS). The cabinet incorporates shielding and interlock circuits to meet regulatory requirements. The cabinet cart is mounted on casters to allow for easy transportation.
Specimen radiography units are utilized to confirm removal of the intended tissue, lesion, or site marker in surgical and core biopsy specimens from various anatomical regions. By generating a high-resolution x-ray image of the specimen, the presence of a lesion, marker or calcification in the extracted sample can be confirmed by the user reviewing the digital image.
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