# K962699: Radworks Medical Imaging Software

- Pathway: 510(k) (Traditional)
- Applicant: Applicare Medical Imaging, B.V.
- Decided: Aug 19, 1996 after 39 days
- Product code: LMD (System, Digital Image Communications, Radiological)
- Device class: 1
- Regulation: 21 CFR 892.2020
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K896095 (1990). 2 ancestors in all.
848 later devices descend from it; 9 cite it directly.
1 of 851 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K911752: Icon Teleradiology System, Icon Medical Systems, Inc. (1991) Summary page 1.
- K896095: Images-on-Call Teleradiology System, Devices & Services Co. (1990) Summary page 1.

## Most influential descendants
- K982862: Radworks Medical Imaging Software with Quality Control Module (1998), 463 descendants of its own
- K981535: Focus Pilot Contouring Workstation (1999), 354 descendants of its own
- K052379: Mim 3.5 (Circa) (2005), 353 descendants of its own
- K060816: Mim 4.0 (Neuro (2006), 350 descendants of its own
- K012211: Efilm Workstation (2001), 333 descendants of its own

## Indications for use
The RadWorks™ Medical Imaging Software is a medical device, and it has the same indications for use and target population as the legally marketed predicate devices.

Source page: https://510kreport.com/device/K962699
Methodology: https://510kreport.com/methodology