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Seno Medical Instruments, Inc.: FDA-registered device maker in San Antonio, TX, United States, 2 510(k) clearances and 1 PMA approval

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

Seno Medical Instruments, Inc. is registered with the FDA (registration 3014755924) in San Antonio, TX, United States. It lists 4 device types. The FDA files 2 510(k) clearances and 1 PMA approval under its listings, the newest dated January 11, 2021. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3014755924
Address: 8023 Vantage Drive, Suite 1000, San Antonio, TX, United States, 78230
Owner or operator: Seno Medical Instruments, Inc. (10082776)
Roles: Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer
First device listed: October 5, 2021
Registered through: 2026
Brand names listed: Imagio Ultrasound Probe, Imagio(R), Imagio(R) Breast Imaging System, Imagio(R) US Probe

Devices it lists

Device	Product code	Class	Role	Source
Optoacoustic Imaging System	QNK	3	Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer	accessdata.fda.gov
System, Imaging, Pulsed Doppler, Ultrasonic	IYN	2	Complaint file establishment, Repackager or relabeler, Specification developer	accessdata.fda.gov
System, Imaging, Pulsed Echo, Ultrasonic	IYO	2	Complaint file establishment, Repackager or relabeler, Specification developer	accessdata.fda.gov
Transducer, Ultrasonic, Diagnostic	ITX	2	Complaint file establishment, Repackager or relabeler, 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 25, 2019	K191007	Aixplorer MACH 30, Aixplorer MACH 20 Ultrasound Diagnostic Systems	IYN	Substantially Equivalent	Supersonic Imagine	accessdata.fda.gov
March 5, 2019	K182628	Imagio Ultrasound Imaging System	IYN	Substantially Equivalent	Seno Medical Instruments, Inc.	accessdata.fda.gov

PMA approvals

Premarket approvals this establishment lists, with the supplements the FDA has decided since.

Approved	PMA number	Device	Product code	Supplements	Latest decision	Source
January 11, 2021	P200003	Imagio Breast Imaging System	QNK	1	June 17, 2022	accessdata.fda.gov

Compare with other makers

Updated June 17, 2022. 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.