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510(k) Data Aggregation
K Number
K080655Device Name
CHRYSALIS
Manufacturer
Date Cleared
2008-05-09
(63 days)
Product Code
Regulation Number
892.1680Why did this record match?
Applicant Name (Manufacturer) :
META IMAGING SOLUTIONS, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The device described here is an accessory to imaging devices previously approved. In general, the intended professional application is described as follows: Breast displacement for imaging purposes with the intention of decreasing radiation dose to the breasts and/or improving image quality. The Chrysalis device is reusable and used external to hospital garb; it does not touch the patient's body.
Device Description
Chrysalis is composed of vinyl-coated polyester, 1/4 inch polyurethane foam headliner, poly-pro webbing, Buckles: 2" side-release plastic buckles
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