RIMED LTD.

Address:25 Hacharoshet Street,RAANANA Central,IL

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Device Description : The Digi-Lite System is indicated for non-invasive evaluation of intracranial an The Digi-Lite System is indicated for non-invasive evaluation of intracranial and extracranial vascular flow velocity irregularities in adults and in children. It is not intended for fetal use. It is not intended for neonatal use. The product includes a Pentium M or equivalent processor, minimum 60 Gbyte hard disc, USB, RS232, LAN 10/100 RJ-45 network connection, a PC keyboard, mouse, touch screen of 15″ TFT color SVGA that provides 1024 × 768 points graphic resolution.

Device Class : 2

Duns Number: 600054688

Premarket Exempt : No

Product Code : ITX, IYN

Prescription Use : Yes

Device Count : 1

- Catalog Number : 400001

Device Description : The Digi-Lite IP color flow imaging system is an ultrasound based system intende The Digi-Lite IP color flow imaging system is an ultrasound based system intended for use in non-invasive vascular evaluation for carotid (extracranial diagnosis), peripheral nerves and musculoskeletal in adults and in children. The Digi Lite IP only contains the hardware and firmware, everything else (e.g. ultrasound software, database) is located on a standard PC that is connected to the Digi Lite IP via USB 2.0. Minimum requirements are given for the PC. The Linear probe is connected to the Digi Lite IP.

Device Class : 2

Duns Number: 600054688

Premarket Exempt : No

Product Code : IYO, IYN, ITX

Prescription Use : Yes

Device Count : 1

- Catalog Number :

Device Description : The Digi-One System is indicated for non-invasive evaluation of intracranial and The Digi-One System is indicated for non-invasive evaluation of intracranial and extracranial vascular flow velocity irregularities in adults and in children.The Rimed Transcarial Doppler Systems are based on a PC platform system. As opposed to the currently approved product Digi-Lite TCD that has the PC component in the device itself, the Digi-One TCD uses a LAN cable to connect and act with any external PC operated with Windows 7 and up

Device Class : 2

Duns Number: 600054688

Premarket Exempt : No

Product Code : IYN, ITX

Prescription Use : Yes

Device Count : 1

Device Description : The Digi-Lite IP Linear Probe is an ultrasonic transducer which generate acousti The Digi-Lite IP Linear Probe is an ultrasonic transducer which generate acoustic signals and also detect returned signals and intended to be used in combination with the Digi-Lite to enable it to perform a medical purpose

Device Class : 2

Duns Number: 600054688

Premarket Exempt : No

Product Code : ITX

Prescription Use : Yes

Device Count : 1

Device Description : The PW 2MHz Ultrasonic Probe is an ultrasonic transducer which generate acoustic The PW 2MHz Ultrasonic Probe is an ultrasonic transducer which generate acoustic signals and also detect returned signals and intended to be used in combination with the RIMED's Transcranial Doppler System.

Device Class : 2

Duns Number: 600054688

Premarket Exempt : No

Product Code : ITX

Prescription Use : Yes

Device Count : 1

Device Description : CW 4MHz Ultrasonic Probe is an ultrasonic transducer which generate acoustic sig CW 4MHz Ultrasonic Probe is an ultrasonic transducer which generate acoustic signals and also detect returned signals and intended to be used in combination with the RIMED's Transcranial Doppler System.

Device Class : 2

Duns Number: 600054688

Premarket Exempt : No

Product Code : ITX

Prescription Use : Yes

Device Count : 1

Device Description : The CW 8MHz Ultrasonic Probe is an ultrasonic transducer which generate acoustic The CW 8MHz Ultrasonic Probe is an ultrasonic transducer which generate acoustic signals and also detect returned signals and intended to be used in combination with the RIMED's Transcranial Doppler System.

Device Class : 2

Duns Number: 600054688

Premarket Exempt : No

Product Code : ITX

Prescription Use : Yes

Device Count : 1