# K162141: Restore PACS

- Pathway: 510(k) (Traditional)
- Applicant: Xian Wingspan Electronic Technology Co., Ltd.
- Decided: Sep 2, 2016 after 32 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: 2 generations back to K083520 (2009). 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)
- K150707: IntelePACS, Intelerad Medical Systems Incorporated (2015) Summary page 4.

## Indications for use
Restore PACS is a device that receives digital medical images and data from various sources (such as, MR scanners, CT Scanners, Digital Xray systems, computers, image gateways or other image sources). Images and other medical data can be communicated, processed, managed, manipulated, stored and displayed within the system and/or across computer networks at distributed locations. Typical users of this system are trained radiologists, technicians, clinicians and nurses.

Source page: https://510kreport.com/device/K162141
Methodology: https://510kreport.com/methodology