# K242838: QuickRad

- Pathway: 510(k) (Traditional)
- Applicant: Aikenist Technologies Pvt, Ltd.
- Decided: Feb 21, 2025 after 155 days
- Product code: LLZ (System, Image Processing, Radiological)
- 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: 8 generations back to K942120 (1994). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K222781: Augmento, Deeptek Medical Imaging Private Limited (2023) Summary page 5.

## Indications for use
QuickRad is a web-based PACS intended for use in radiology centers, diagnostic labs, and hospitals. It is designed to receive, store, transmit, process, and display medical images and associated data from various DICOM-compliant sources, including CT scanners, MRI systems, ultrasound machines, and X-ray devices. The system enhances communication and accessibility by allowing distributed access to images and data across computer networks. QuickRad also offers optional integration with FDA-cleared third-party Al models, enabling the visualization of Al-generated outputs. The system displays these outputs "as-is," with the safety and effectiveness of the Al models being covered under the original third-party manufacturer's regulatory clearance. Mammographic images may only be interpreted using a monitor that meets the technical specifications identified by the FDA. The system is designed for utilization by proficient and certified medical practitioners, including physicians, radiologists, and medical technicians.

Source page: https://510kreport.com/device/K242838
Methodology: https://510kreport.com/methodology