TERATECH CORPORATION

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Transducer, Ultrasonic, Diagnostic (ITX) (10) System, Imaging, Pulsed Doppler, Ultrasonic (IYN) (9) System, Imaging, Pulsed Echo, Ultrasonic (IYO) (9)

Premarket Exempt

Clear

Terason - 00852698007102 Catalog Number :

Device Description : The Teratech Corporation Terason uSmart3300 is a general purpose Ultrasound Syst 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.

Device Class : 2

Duns Number: 836416321

Premarket Exempt : No

Product Code : IYO, IYN, ITX

Prescription Use : Yes

Device Count : 1

Terason - 00852698007119 Catalog Number :

Device Description : The Terason uSmart3200T is a general purpose Ultrasound System intended for use 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.

Device Class : 2

Duns Number: 836416321

Premarket Exempt : No

Product Code : IYO, IYN, ITX

Prescription Use : Yes

Device Count : 1

Terason - 00852698007126 Catalog Number :

Device Description : The Terason uSmart3300 Cart is used to provide a portable-solution-on-wheels for The Terason uSmart3300 Cart is used to provide a portable-solution-on-wheels for the Terason uSmart3300 ultrasound imaging system.

Device Class : 2

Duns Number: 836416321

Premarket Exempt : No

Product Code : IYN, IYO, ITX

Prescription Use : Yes

Device Count : 1

Terason - 00852698007133 Catalog Number :

Device Description : The Terason uSmart3300 MUX is an electronic device intended to be used with an u The Terason uSmart3300 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 uSmart3300 Cart.

Device Class : 2

Duns Number: 836416321

Premarket Exempt : No

Product Code : IYN, IYO, ITX

Prescription Use : Yes

Device Count : 1

Terason - 00852698007140 Catalog Number :

Device Description : The Terason 15L4A is a general-purpose high-frequency linear transducer. The int The Terason 15L4A is a general-purpose high-frequency linear transducer. The intended uses include: ophthalmic, abdominal, pediatric, small organ, musculoskeletal (conventional and superficial), and peripheral vascular ultrasound imaging.

Device Class : 2

Duns Number: 836416321

Premarket Exempt : No

Product Code : ITX

Prescription Use : Yes

Device Count : 1

Terason - 00852698007157 Catalog Number :

Device Description : The Terason uSmart3200T Cart is used to provide a portable-solution-on-wheels fo The Terason uSmart3200T Cart is used to provide a portable-solution-on-wheels for the Terason uSmart3200T ultrasound imaging system.

Device Class : 2

Duns Number: 836416321

Premarket Exempt : No

Product Code : IYN, IYO, ITX

Prescription Use : Yes

Device Count : 1

Terason - 00852698007164 Catalog Number :

Device Description : The Terason uSmart3200T Roller Bag is a self-contained suitcase on wheels. The T The Terason uSmart3200T Roller Bag is a self-contained suitcase on wheels. The Terason uSmart3200T Tablet and associated transducers neatly fit inside the suitcase for easy transportation.

Device Class : 2

Duns Number: 836416321

Premarket Exempt : No

Product Code : IYN, IYO, ITX

Prescription Use : Yes

Device Count : 1

Terason - 00852698007171 Catalog Number :

Device Description : The Terason uSmart3300 Roller Bag is a self-contained suitcase on wheels. The Te The Terason uSmart3300 Roller Bag is a self-contained suitcase on wheels. The Terason uSmart3300 and associated transducers neatly fit inside the suitcase for easy transportation.

Device Class : 2

Duns Number: 836416321

Premarket Exempt : No

Product Code : IYN, IYO, ITX

Prescription Use : Yes

Device Count : 1

Terason - 00852698007188 Catalog Number :

Device Description : The Terason uSmart3200T MUX is an electronic device intended to be used with an 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.

Device Class : 2

Duns Number: 836416321

Premarket Exempt : No

Product Code : ITX, IYN, IYO

Prescription Use : Yes

Device Count : 1

Terason - 00852698007218 Catalog Number :

Device Description : Terason uSmart3200T R2/Nexgen ultrasound system

Device Class : 2

Duns Number: 836416321

Premarket Exempt : No

Product Code : IYO, IYN, ITX

Prescription Use : Yes

Device Count : 1

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