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Exact Imaging

US

Last updated May 23, 2026

Information

Country: US
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Catalogue (15)

Device	Model / Reference	Registries	Class	Status
Non-Sterile Reusable Needle Guide - 16GA	EV-BIOG-R16	FDA UDI	Class II	Active
EV5C Abdominal Transducer	EV5C	FDA UDI	Class II	Active
ExactVu High Resolution Micro-Ultrasound System	1.0	FDA UDI	Class II	Active
Reusable Needle Guide for use with the Exact Imaging EV29L Transducer	Single Unit	FDA UDI	Class II	Active
EV9C Transrectal Transducer	EV9C	FDA UDI	Class II	Active
Sterile transrectal needle guide with sheath	Single Unit	FDA UDI	Class II	Active
ExactVu High Resolution Micro-Ultrasound System	1.0	FDA UDI	Class II	Active
Needle Guide for use with the Exact Imaging EV29L Transducer	Single Unit	FDA UDI	Class II	Active
EV29L Non-Sterile Reusable PrecisionPoint Adapter	EV-BIOGR-PP	FDA UDI	Class II	Active
EV29L Transrectal Transducer	EV29L	FDA UDI	Class II	Active
Sterile transperineal needle guide with sheath	Single Unit	FDA UDI	Class II	Active
ExactVu High Resolution Micro-Ultrasound System	K180636	FDA 510(k)	Class II	Active
ExactVu High Resolution Micro-Ultrasound System	K190995	FDA 510(k)	Class II	Active
ExactVu High Resolution Micro-Ultrasound System	K192303	FDA 510(k)	Class II	Active
ExactVu High Resolution Micro-Ultrasound System	K162972	FDA 510(k)	Class II	Active

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FDA Establishments (1)

Establishments registered with the FDA under this company group, matched by name.

Exact Imaging, Inc. Markham Ontario · CA FEI 3012402886