UltraSight AI Guidance
by Ultrasight, Inc. 510(k)
Active
510(k) K223347
Overview
The UltraSight AI Guidance is a Class II medical device classified as “Image Acquisition and/or Optimization Guided by Artificial Intelligence.” It uses artificial‑intelligence algorithms to assist clinicians in acquiring and optimizing ultrasound images, supporting focused echocardiography examinations. The system is intended for use in radiology settings.
The device received traditional FDA 510(k) clearance (K223347) on 24 July 2023, with a decision of substantially equivalent and an advisory committee review by Radiology (RA). It is identified by product code QJU and is regulated under 21 CFR 892.2100. The device is supplied by Ultrasight, Inc. in Rehovot, Israel.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK223347 | Date24 Jul 2023 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- QJU
- Device Class
- Class II
- Regulation
- 21 CFR Part 892.2100
- Advisory Committee
- Radiology
- FDA Decision
- SESE Substantially Equivalent
Other devices from Ultrasight, Inc.
Questions
What is the UltraSight AI Guidance device used for?
The UltraSight AI Guidance is a Class II medical device that uses artificial intelligence algorithms to assist clinicians in acquiring and optimizing ultrasound images, specifically supporting focused echocardiography examinations in radiology settings.
How is the UltraSight AI Guidance supplied?
The device is supplied by Ultrasight, Inc., located at 1 Hamada St., Rehovot, Israel, with contact person Davidi Vortman. It is distributed as a medical imaging assistance tool for clinical use.
What is the regulatory status of the UltraSight AI Guidance?
The UltraSight AI Guidance received traditional FDA 510(k) clearance (K223347) on July 24, 2023, with a decision of substantially equivalent. It is classified under product code QJU and regulated under 21 CFR 892.2100, with an advisory committee review by Radiology (RA).
Is the UltraSight AI Guidance a single-use or reusable device?
The device information does not specify whether the UltraSight AI Guidance is designed for single-use or multiple reuse. This detail would be found in the device's specific usage instructions or labeling materials provided by the manufacturer.