FDA.reportPublic FDA data

SENO MEDICAL INSTRUMENTS, INC.

Matched from indexed company URL: Seno Medical Instruments, Inc.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30147559243014755924SENO MEDICAL INSTRUMENTS, INC.1N2026-01-018023 Vantage Drive, Suite 1000 San Antonio TX US 78230

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00864802000442Imagio® - Transducer (OA/US Probe) Model 8100888-978-8835service@senomedical.com
00864802000459Imagio® - Imagio Breast Imaging System Model 9100888-978-8835service@senomedical.com
00864802000466Imagio® - US L18-5 Probe888-978-8835service@senomedical.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2966791661801159P200003Imagio Breast Imaging SystemQNK2021-01-11
2966791203701636K191007Aixplorer MACH 30, Aixplorer MACH 20 Ultrasound Diagnostic SystemsIYN2019-10-25
2966791469735321K182628Imagio Ultrasound Imaging SystemIYN2019-03-05

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
IYN22019-10-25
QNK 12021-01-11

PMA#

Imagio® Breast Imaging system

2022-06-17

Seno Medical Instruments, Inc.8023 Vantage Drive, Suite 1000san Antonio, TX 78230 PMA NumberP200003 Supplement NumberS001 Date Received11/01/2021 Decision Date06/17/2022 Product Code QNK  Advisory Committee Radiology Supplement Typenormal 180 Day Track Supp...

PMN#

GUDID#