Digi-One
RIMED LTD.
RIMED LTD
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 9616774 | 3002494651 | RIMED LTD | 1 | N | 2026-01-01 | 25 Hacharoshet Street Industrial Park Raanana RAANANA Central IL 4365613 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 17475 | 1054555110 | K974588 | INTRA-VIEW BILATERAL TRANSCRANIAL DOPPLER DEVICE, SMART-LITE PORTABLE BILATERAL TRANSCRANIAL DOPPLER DEVICE, COMPACT MOD | IYN | 1998-08-07 |
| 17475 | 1719978705 | K163121 | SmartUs EXT-1M/3M | IYN | 2017-08-10 |
| 17475 | 1444334061 | K143476 | Digi-One | IYN | 2015-06-23 |
| 17475 | 1276425377 | K113184 | LOGICSCAN 64 LOGICSCAN 128 | IYN | 2012-01-26 |
| 17475 | 1248341850 | K062578 | DIGI-LITE TCD DEVICE | IYN | 2006-09-18 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| IYN | 8 | 2017-08-10 |
PMN#
GUDID#
CW 8MHz Ultrasonic Probe - 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.
2016-09-24
CW 4MHz Ultrasonic Probe - 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.
2016-09-24
PW 2MHz Ultrasonic Probe - 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.
2016-09-24
Digi-Lite IP Linear Probe - 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
2016-09-24
Digi-One - 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
2016-09-24
Digi-Lite IP - 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.
2016-09-24
Digi-Lite - 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.
2016-09-24