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Current State of the Regulatory Trajectory for Whole Slide Imaging Devices in the USA

The regulatory field for digital pathology (DP) has advanced significantly. A major milestone was accomplished when the FDA allowed the first vendor to market their device for primary diagnostic use in the USA and published in the classification order that this device, and substantially equivalent d...

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Dettagli Bibliografici
Pubblicato in:J Pathol Inform
Autori principali: Abels, Esther, Pantanowitz, Liron
Natura: Artigo
Lingua:Inglês
Pubblicazione: Medknow Publications & Media Pvt Ltd 2017
Soggetti:
Accesso online:https://ncbi.nlm.nih.gov/pmc/articles/PMC5450449/
https://ncbi.nlm.nih.gov/pubmed/28584684
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.4103/jpi.jpi_11_17
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