Exact Imaging - ExactVu - Certifications, Declarations, and Authorizations

Certifications, Declarations, and Authorizations

This page presents Exact Imaging's certifications, declarations, and authorizations.

Certificates

Type	File Name
	ISO 13485-2016 Certificate
	MDSAP Certificate
	EU MDR Certificate

Declarations

Type	File Name
	EU MDR Declaration of Conformity
	EU 2023-1230 Declaration of Conformity
	Exact Imaging REACH statement

Authorizations

Type	File Name
	PRRC memo

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Exact Imaging is LSO’s
2019 Company of the Year

ExactVu™, Exact Imaging™, PRI-MUS™, FusionVu™, Cognitive Assist™ and ExactVu Micro Doppler™ are trademarks of Exact Imaging.

ExactVu™ micro-ultrasound system is available for sale in the European Union (CE Mark), the United States (FDA 510(k) clearance), and in Canada (Health Canada license).