FDA.reportPublic FDA data

TERATECH CORP.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30023158403002315840TERATECH CORP.1N2026-01-0177-79 Terrace Hall Ave BURLINGTON MA US 01803

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
00852698007089Terason - The Terason PDOF is a general-purpose Doppler transducer. The intended uses include: adult and pediatric cardiac ultrasound Doppler imaging.8668372766techsupport@terason.com
00852698007188Terason - The Terason uSmart3200T MUX is an electronic device intended to be used with an ultrasound (US) imaging system to enable the simultaneous connection of multiple hand-held ultrasound transducers so the user can conveniently switch between transducers as required. The unit with multiple transducer ports and is attached to the Terason uSmart3200T Cart.8668372766techsupport@terason.com
00852698007218Terason - Terason uSmart3200T R2/Nexgen ultrasound system866-837-2766techsupport@terason.com
00852698007300Terason - AC/DC Medical Grade Power Adapter with AC Cord8668372766techsupport@terason.com
00852698007386Terason - Triple Programmable USB Foot Switch with Freeze, Save, Store Functions8668372766techsupport@terason.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
565211058386392K201633Terason uSmart 3200T Plus Ultrasound SystemIYN2020-07-02
565211561027688K193510Terason uSmart3200T Ultrasound SystemIYN2020-01-28
565211013332335K150533Terason uSmart3200T Ultrasound SystemIYN2015-05-09
565211035469807K150148Terason uSmart3300 Ultrasound SystemIYN2015-02-20
565211477220987K140834TERASON USMART3400 ULTRASOUND SYSTEMIYN2014-04-25
565211425055111K140773TERASON USMART3300 ULTRASOUND SYSTEMIYN2014-05-30
565211988741234K140524TERASON USMART3200 AND BENQ UP200ULTRASOUND SYSTEMIYN2014-03-21
565211595855444K131209TERASON USMART3200T ULTRASOUND SYSTEMIYN2013-05-24
565212029089765K112953TERASON T3000 ULTRASOUND SYSTEMS WITH UPDATED NEEDLE GUIDANCE GRAPHICSIYN2012-02-03
565211514393496K110020TERASON T3200 ULTRASOUND SYSTEMITX2011-01-20
565211625894609K051334TERASON ULTRASOUND SYSTEM WITH CONTINUOUS WAVE SOPPLERIYN2005-06-03

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
IYN102020-07-02
ITX12011-01-20

PMN#

GUDID#

Terason - The Terason uSmart3200T is a general purpose Ultrasound System intended for use by a qualified physician for evaluation by ultrasound imaging or fluid flow analysis of the human body. Specific clinical applications and exam types include: Ophthalmic, Fetal, Abdominal, Intraoperative (Spec. and Neuro.), Pediatrics, Small Organ (Thyroid, Breast, Testes); Neonatal and Adult Cephalic, Trans-rectal, Trans-vaginal, Trans-esophageal (non-cardiac), Musculoskeletal (Conventional and Superficial), Cardiac (Adult & Pediatric), Trans-esophageal (cardiac), and Peripheral Vascular.

TERATECH CORPORATION

2018-04-06

Terason - The Teratech Corporation Terason uSmart3300 is a general purpose Ultrasound System intended for use by a qualified physician for evaluation by ultrasound imaging or fluid flow analysis of the human body. Specific clinical applications and exam types include: Ophthalmic, Fetal, Abdominal, Intraoperative (Spec. and Neuro.), Pediatrics, Small Organ (Thyroid, Breast, Testes); Neonatal and Adult Cephalic, Trans-rectal, Trans-vaginal, Trans-esophageal (non-cardiac), Musculoskeletal (Conventional and Superficial); Cardiac (Adult & Pediatric); Trans-esophageal (cardiac) Peripheral Vascular.

TERATECH CORPORATION

2018-04-06