# K973959: Olicon Imaging Systems, Inc. 02-Workstation and/or Pacsview Software

- Pathway: 510(k) (Traditional)
- Applicant: Olicon Imaging Systems, Inc.
- Decided: Dec 22, 1997 after 67 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 K922164 (1993). 1 ancestor in all.
380 later devices descend from it; 6 cite it directly.
1 of 382 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K922164: Raytel Digital Imaging Systems, Olicon Imaging Systems, Inc. (1993) Summary page 1.

## Most influential descendants
- 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
- K071964: Mim 4.1 (Seastar) (2007), 287 descendants of its own
- K091373: Syngo Trued (2009), 200 descendants of its own

## Indications for use
The Olicon 02-Workstation and/or PACSView™ Software is a device that receives digital images and data from various image sources, (including but not limited to CT Scanners, MR Scanners, Ultrasound systems, R/F Units, Computed & Direct Radiographic devices, secondary capture devices, scanners, imaging gateways, or other imaging sources). Images/data can be stored, communicated, processed, and displayed within the workstation and or across computer networks at distributed locations. Typical users of this system are trained professionals, including but not limited to physicians, nurses and medical technicians.

Source page: https://510kreport.com/device/K973959
Methodology: https://510kreport.com/methodology