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510(k) Data Aggregation
K Number
K150415Device Name
NilRead
Manufacturer
Date Cleared
2015-06-12
(114 days)
Product Code
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
Perceptive Software
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The NilRead software application provides desktop and portable access to multi-modality softcopy medical images, reports and other patient related information for conducting diagnostic review, planning, and reporting through the interactive display and manipulation of medical data, including mammography and breast tomosynthesis. NilRead also allows users to collaborate by sharing application sessions.
Lossy compressed mammographic images are not intended for diagnostic review. Mammographic images should only be viewed with a monitor approved by FDA for viewing mammographic images. For primary diagnosis, post process DICOM "for presentation" images must be used.
On mobile platforms, this device is not intended for diagnostic use.
Device Description
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