Data / Medical devices / Canada / Exact Imaging, Inc.

Exact Imaging, Inc.: FDA-registered device maker in Markham Ontario, Canada, 5 510(k) clearances

Name: Exact Imaging, Inc. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Exact Imaging, Inc. is registered with the FDA (registration 3012402886) in Markham Ontario, Canada. It lists 5 device types. The FDA files 5 510(k) clearances under its listings, the newest dated October 1, 2019. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3012402886
Address: 7676 Woodbine Avenue Unit 15, Markham Ontario, Canada, L3R 2N2
Owner or operator: Exact Imaging, Inc. (10053728)
Roles: Exporter to the US, Manufacturer, Specification developer
First device listed: January 5, 2017
Registered through: 2026
Brand names listed: EV29L High Resolution Side-Fire Transducer, EV29L High Resolution Transrectal Side-Fire Transducer, EV29L High Resolution Transrectal Side-Fire transducer, EV29L Non-Sterile Reusable Transrectal Needle Guides, EV29L Reusable Needle Guide, EV29L Reusable Transrectal Needle Guide (16 & 18 GA), EV29L Sterile Biopsy Needle Guide, EV29L Sterile Transperineal Needle Guide and more

Devices it lists

Device	Product code	Class	Role	Source
Biopsy Needle Guide Kit	OIJ	2	Manufacturer, Specification developer	accessdata.fda.gov
System, Applicator, Radionuclide, Manual	IWJ	1	Exporter to the US	accessdata.fda.gov
System, Imaging, Pulsed Doppler, Ultrasonic	IYN	2	Manufacturer, Specification developer	accessdata.fda.gov
System, Imaging, Pulsed Echo, Ultrasonic	IYO	2	Manufacturer, Specification developer	accessdata.fda.gov
Transducer, Ultrasonic, Diagnostic	ITX	2	Exporter to the US, Manufacturer, Specification developer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
October 1, 2019	K192303	ExactVu High Resolution Micro-Ultrasound System	IYN	Substantially Equivalent	Exact Imaging, Inc.	accessdata.fda.gov
May 10, 2019	K190995	ExactVu High Resolution Micro-Ultrasound System	IYN	Substantially Equivalent	Exact Imaging, Inc.	accessdata.fda.gov
April 30, 2018	K180636	ExactVu High Resolution Micro-Ultrasound System	IYO	Substantially Equivalent	Exact Imaging, Inc.	accessdata.fda.gov
December 2, 2016	K162972	ExactVu High Resolution Micro-Ultrasound System	IYO	Substantially Equivalent	Exact Imaging	accessdata.fda.gov
April 21, 1999	K990175	SHEATHES (NON-LATEX), STERILE	ITX	Substantially Equivalent	Sheathing Technologies, Inc.	accessdata.fda.gov

Compare with other makers

Updated October 1, 2019. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.