# K083618: Pacs Scan

- Pathway: 510(k) (Traditional)
- Applicant: Pacsgear, Inc.
- Decided: Jan 28, 2009 after 51 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: 3 generations back to K896095 (1990). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K982862: Radworks Medical Imaging Software with Quality Control Module, Applicare Medical Imaging, B.V. (1998) Summary page 1.

## Most influential descendants
- K131392: Etiam Pacs Components (2013), 0 descendants of its own

## Indications for use
The PacsSCAN Medical Imaging Software with QC Module is intended to be used by authorized staff to perform various quality control operations on PACSGEAR imaging studies before they are made available to other locations in the network. These operations include scanning film images, capturing video images, confirming or editing patient demographics, reviewing the history of the study, adding or removing images, combining with another study, renumbering images, editing patient orientation information, and setting or editing routing information.

Source page: https://510kreport.com/device/K083618
Methodology: https://510kreport.com/methodology