# K982862: Radworks Medical Imaging Software with Quality Control Module

- Pathway: 510(k) (Traditional)
- Applicant: Applicare Medical Imaging, B.V.
- Decided: Oct 21, 1998 after 69 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 K896095 (1990). 3 ancestors in all.
463 later devices descend from it; 7 cite it directly.
0 of 467 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K962699: Radworks Medical Imaging Software, Applicare Medical Imaging, B.V. (1996) Summary page 1.

## Most influential descendants
- K012211: Efilm Workstation (2001), 333 descendants of its own
- K020995: Efilm Workstation with Modules (2002), 321 descendants of its own
- K032401: Orthoview (2003), 133 descendants of its own
- K042816: Traumacad 1.2 (2004), 129 descendants of its own
- K073714: Traumacad Version 2.0 (2008), 117 descendants of its own

## Indications for use
The RadWorks Medical Imaging Software, from Applicare Medical Imaging, B.V., when installed on an appropriate hardware platform, is intended to provide capability for the acceptance, display, storage, and digital processing of medical images. Options allow for additional capability, including transmission of images over local area networks or public communications channels, digitization of film images, acceptance of digital images directly from different medical image modalities, and quality control review and revision of studies.

Source page: https://510kreport.com/device/K982862
Methodology: https://510kreport.com/methodology
