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510(k) Data Aggregation
K Number
K122119Device Name
DX-D FULL LEG FULL SPINE
Manufacturer
Date Cleared
2012-09-13
(58 days)
Product Code
Regulation Number
892.1680Why did this record match?
Applicant Name (Manufacturer) :
AFGA HEALTHCARE N.V.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Agfa's DX-D FLFS is indicated for acquiring images for measurements in the orthopedic field (skeleton).
Device Description
Agfa's DX-D FLFS is a direct radiography accessory, similar to the predicate. The device allows the user to stitch multiple acquired images of long patient anatomies (like a full leg or full spine) into a single patient image. This is particularly useful for making measurements during orthopedic examinations. The DX-D FLFS includes an optional software license for its NX workstation (for image processing) and a patient stand with grid.
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