RealNow
by YIWEI Medical Technology Co., Ltd 510(k)
Active
510(k) K213891
Overview
The RealNow is a Medical Image Management and Processing System (Product Code: LLZ), designed for the acquisition, analysis, and display of radiological images. It facilitates diagnostic workflows by enabling real-time processing, storage, and retrieval of imaging data, supporting radiologists in interpreting studies such as CT, MRI, and X-ray scans.
This system is intended for use in radiology departments and clinical imaging centers, where it is supplied as a software-based solution integrated with imaging modalities. It is classified as Class II under 21 CFR 892.2050 and has received FDA 510(k) clearance (K213891) as substantially equivalent to a predicate device. The device operates as a reusable software platform, with no explicit sterility requirements, and is intended for MRI-safe environments as per its design specifications.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK213891 | Date24 Feb 2023 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- LLZ
- FDA applicant
- Yiwei Medical Technology Co., Ltd.
- Device Class
- Class II
- Regulation
- 21 CFR Part 892.2050
- Advisory Committee
- Radiology
- FDA Decision
- SESE Substantially Equivalent
Other devices from YIWEI Medical Technology Co., Ltd
Questions
What types of imaging studies can the RealNow system process and display for diagnostic purposes?
The RealNow system is designed to handle and analyze radiological images from common imaging modalities such as CT (computed tomography), MRI (magnetic resonance imaging), and X-ray scans. Its real-time processing capabilities support radiologists in interpreting these studies efficiently, streamlining diagnostic workflows in radiology departments and clinical imaging centers.
Is the RealNow system a single-use or reusable device, and are there any sterility requirements?
The RealNow is a reusable software-based platform and does not have sterility requirements since it is not a physical medical device that comes into direct contact with patients. It operates as a digital solution integrated with imaging equipment, ensuring long-term use in MRI-safe environments.
How is the RealNow system supplied, and what kind of environment is it intended for?
The RealNow system is supplied as a software solution that integrates with imaging modalities like CT, MRI, and X-ray machines. It is specifically designed for use in radiology departments and clinical imaging centers, with a focus on MRI-safe environments as part of its operational specifications.
What regulatory pathway did the RealNow system follow to gain market authorization, and what does this mean for its classification?
The RealNow system received FDA 510(k) clearance under the traditional review pathway, classified as substantially equivalent to a predicate device. It is categorized under 21 CFR 892.2050 as a Class II medical device, which reflects its role in facilitating diagnostic workflows without the higher scrutiny of Class III devices.