# K981535: Focus Pilot Contouring Workstation

- Pathway: 510(k) (Traditional)
- Applicant: Computerized Medical Systems, Inc.
- Decided: Apr 2, 1999 after 338 days
- Product code: IYE (Accelerator, Linear, Medical)
- Device class: 2
- Regulation: 21 CFR 892.5050
- 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). 6 ancestors in all.
354 later devices descend from it; 1 cites it directly.
1 of 361 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K961160: Upacs Version 1.7, Base Ten Systems, Inc. (1996) Summary page 1.
- K962699: Radworks Medical Imaging Software, Applicare Medical Imaging, B.V. (1996) Summary page 1.
- K973959: Olicon Imaging Systems, Inc. 02-Workstation and/or Pacsview Software, Olicon Imaging Systems, Inc. (1997) Summary page 1.

## Most influential descendants
- K052379: Mim 3.5 (Circa) (2005), 353 descendants of its own
- K060816: Mim 4.0 (Neuro (2006), 350 descendants of its own
- K071964: Mim 4.1 (Seastar) (2007), 287 descendants of its own
- K091373: Syngo Trued (2009), 200 descendants of its own
- K062163: Mimviewer (2006), 166 descendants of its own

## Indications for use
The FOCUS Pilot Contouring Workstation permit contouring of patient tumors and critical structures on images (CT slices) at a workstation remote from the FOCUS Radiation Treatment Planning System. Images are drawn from the FOCUS RTP System, contoured and then returned to the FOCUS RTP System for completion of the treatment planning activity.

Source page: https://510kreport.com/device/K981535
Methodology: https://510kreport.com/methodology