# K222174: RadioLens v1.0

- Pathway: 510(k) (Traditional)
- Applicant: Synapsica
- Decided: Mar 28, 2023 after 250 days
- Product code: QIH (Automated Radiological Image Processing Software)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K022585 (2002). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K221632: Spine CAMP™, Medical Metrics, Inc. (2022). Cleared while this submission was under review Summary page 4.

## Indications for use
RadioLens v1.0 software is a medical diagnostic application that displays, processes, stores, and transfers DICOM data, with the exception of mammography. It provides the capability to store images and patient information, perform filtering, digital manipulation, and quantitative measurements. The client software is designed to run on standard personal and business computers. RadioLens v1.0 includes an optional SpindleX module which is used to analyze potential vertebral body displacements in spine, either absolute or relative, using cervical/lumbar digital X-Rays of spine. A qualified medical practitioner may use the module to semi-automatically identify relevant spine anatomy and calculate vertebral displacement measurements. Measurements are then used to determine severity and location of any spinal ligament injury leading to subluxation using criteria published in AMA Guides to The Evaluation of Permanent Impairment, 5th & 6th edition. SpindleX is meant for assistance with analysis of spinal ligament injury in the adult population (>18 years of age) as captured in stress x-rays. SpindleX is not meant for patients that have undergone surgery or other traumatic injury that result in distortion of spinal anatomy.

Source page: https://510kreport.com/device/K222174
Methodology: https://510kreport.com/methodology