RadioLens v1.0
by Synapsica 510(k)
Active
510(k) K222174
Overview
RadioLens v1.0 is a medical diagnostic imaging software system designed for viewing, analyzing, and reporting on DICOM-format radiology images. It integrates an AI module for automated analysis and measurement of spinal ligament injuries in digital stress X-rays of the cervical and lumbar spine, assisting radiologists and clinicians in diagnostic workflows.
The device is supplied as a software application for use in radiology settings, functioning as a standalone medical image management and processing system. It is intended for single-use in diagnostic imaging workflows and has received FDA 510(k) clearance under the Radiology advisory committee, with K222174 as the assigned clearance number.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK222174 | Date28 Mar 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- Withdrawn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
- QIH
- Device Class
- Class II
- Regulation
- 21 CFR Part 892.2050
- Advisory Committee
- Radiology
- FDA Decision
- SESE Substantially Equivalent
Questions
What specific types of spinal injuries does RadioLens v1.0 help identify in X-ray images, and how does it assist radiologists in their workflow?
RadioLens v1.0 is designed to assist radiologists by automating the analysis and measurement of spinal ligament injuries in digital stress X-rays of the cervical and lumbar spine. The AI module within the software scans DICOM-format images to highlight potential ligament damage, reducing manual review time and improving diagnostic accuracy in clinical settings.
Is RadioLens v1.0 a standalone software solution, or does it require integration with existing radiology systems?
RadioLens v1.0 functions as a standalone medical imaging software system, meaning it does not require integration with other radiology platforms. It is built to handle DICOM-format images independently, making it suitable for use in diagnostic workflows where standalone processing is preferred.
How is RadioLens v1.0 supplied, and is it intended for single-use or repeated use in a clinical setting?
RadioLens v1.0 is supplied as a software application for installation on radiology workstations. According to its design, it is intended for single-use in diagnostic imaging workflows, though the software itself can be reused across multiple patient sessions as long as it remains within its intended clinical environment.
What regulatory pathway did RadioLens v1.0 follow to achieve clearance, and which advisory committee was involved?
RadioLens v1.0 received FDA 510(k) clearance under the Radiology advisory committee (RA). The clearance was granted through a traditional 510(k) review, with the assigned clearance number being K222174. This process confirmed its substantial equivalence to a predicate device under the Radiology (QIH) product code category.