FDA.reportPublic FDA data

SONOCINE, INC

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30075033733007503373SONOCINE, INC1N2020-04-258850 Terabyte Ct Suite I Reno NV US 89521

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
B3015017750001SonoCine Image Acquisition Station - SonoCiné Image Acquisition Station Model 201, PN 501775000 is an accessory to ultrasound imaging Systems facilitating their use as an adjunct to mammography for B-mode ultrasonic screening imaging of the breast when used with a linear array transducer consisting of the following components: Image Acquisition Station Model 201 – PN 501775-000, Image Acquisition Station Software Application V3.1.x, PN 501642, Reading Station Software Application, V3.1.x, PN 501973.7758517474support@sonocine.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1009071081826841K082543SONOCINE ADJUNCTIVE BREAST ULTRASOUND SYSTEM (ABU), MODEL 100IYO2008-10-14

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
IYO12008-10-14

PMN#

GUDID#

SonoCine Image Acquisition Station - SonoCiné Image Acquisition Station Model 201, PN 501775000 is an accessory to ultrasound imaging Systems facilitating their use as an adjunct to mammography for B-mode ultrasonic screening imaging of the breast when used with a linear array transducer consisting of the following components: Image Acquisition Station Model 201 – PN 501775-000, Image Acquisition Station Software Application V3.1.x, PN 501642, Reading Station Software Application, V3.1.x, PN 501973.

SONOCINE, INC.

2016-09-23