ExactVu High Resolution Micro-Ultrasound System
Exact Imaging Inc.
EXACT IMAGING, INC.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3012402886 | 3012402886 | EXACT IMAGING, INC. | 1 | N | 2026-01-01 | 7676 Woodbine Avenue Unit 15 Markham Ontario CA L3R 2N2 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 203383 | 1657856969 | K990175 | SHEATHES (NON-LATEX), STERILE | ITX | 1999-04-21 |
| 203383 | 2057512619 | K192303 | ExactVu High Resolution Micro-Ultrasound System | IYN | 2019-10-01 |
| 203383 | 1442420566 | K190995 | ExactVu High Resolution Micro-Ultrasound System | IYN | 2019-05-10 |
| 203383 | 1191435775 | K180636 | ExactVu High Resolution Micro-Ultrasound System | IYO | 2018-04-30 |
| 203383 | 2008263003 | K162972 | ExactVu High Resolution Micro-Ultrasound System | IYO | 2016-12-02 |
| 203383 | 1705044519 |
Product Codes Associated With Registrations#
PMN#
ExactVu High Resolution Micro-Ultrasound System
Exact Imaging, Inc.
ExactVu High Resolution Micro-Ultrasound System
Exact Imaging Inc.
ExactVu High Resolution Micro-Ultrasound System
Exact Imaging
GUDID#
EV29L Non-Sterile Reusable PrecisionPoint Adapter - The EV29L Non-Sterile Reusable PrecisionPoint Adapter is used with the EV29L High Resolution transrectal side fire transducer (UHR-TRUS) for the ExactVu™ high resolution micro-ultrasound system, and the Perineologic PrecisionPoint transperineal needle guide. The adapter shall allow the PrecisionPoint guide to be attached to the EV29L transducer for use with transperineal biopsy.
2025-05-05
Needle Guide for use with the Exact Imaging EV29L Transducer - The EV29L Sterile Biopsy Needle Guide is a specially designed biopsy needle guide for use with the EV29L transducer.
2017-02-08
Sterile transperineal needle guide with sheath - Sterile transperineal needle guide with sheath for use with the EV29L transducer.
2021-02-03
Sterile transrectal needle guide with sheath - Sterile transrectal needle guide with sheath for use with the Exact Imaging EV29L Transducer
2021-02-03
Non-Sterile Reusable Needle Guide - 16GA - Non-Sterile Reusable Transrectal Needle Guide for use with the Exact Imaging EV29L Transducer
2022-05-13
Reusable Needle Guide for use with the Exact Imaging EV29L Transducer - The EV29L Reusable Needle Guide is a specially designed biopsy needle guide for use with the EV29L transducer.
2018-06-01
EV5C Abdominal Transducer - EV5C is an abdominal end-fire transducer.
2021-02-03
Sterile transperineal needle guide with sheath - Sterile transperineal needle guide with sheath for use with the EV29L transducer.
2021-02-03
Sterile transrectal needle guide with sheath - Sterile transrectal needle guide with sheath for use with the Exact Imaging EV29L Transducer
2021-02-03
Needle Guide for use with the Exact Imaging EV29L Transducer - The EV29L Sterile Biopsy Needle Guide is a specially designed biopsy needle guide for use with the EV29L transducer.
2017-02-08
ExactVu High Resolution Micro-Ultrasound System - The ExactVu high resolution micro-ultrasound system is intended for use by qualified medical professionals for diagnostic ultrasound imaging, data processing and guidance of puncture and biopsy. The ExactVu System is comprised of transducers responsible for ultrasound signal generation and recording, a needle guide and a main unit that controls the transducers, processes the acoustic data, and processes and displays images.
2017-02-08
ExactVu High Resolution Micro-Ultrasound System - The ExactVu high resolution micro-ultrasound system is intended for use by qualified medical professionals for diagnostic ultrasound imaging, data processing and guidance of puncture and biopsy. The ExactVu System is comprised of transducers responsible for ultrasound signal generation and recording, a needle guide and a main unit that controls the transducers, processes the acoustic data, and processes and displays images.
2017-02-08
EV29L Transrectal Transducer - EV29L is a 29 MHz high resolution transrectal side-fire transducer.
2017-02-08
EV9C Transrectal Transducer - EV9C is a transrectal end-fire transducer.
2017-02-08