# K973793: Olicon Imaging Systems, Inc. Gateway and/or Software

- Pathway: 510(k) (Traditional)
- Applicant: Olicon Imaging Systems, Inc.
- Decided: Dec 17, 1997 after 72 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 K963592 (1996). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K963592: Imageshare Protocol Converting Gateway and/or Software [OS/2 Warp] 1OOO,[Sun/Solaris] 2000, Dejarnette Research Systems (1996) Summary page 1.

## Indications for use
The Olicon Gateway is a uni-directional 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, imaging gateways, or other imaging sources). The incoming data formats are ACR-NEMA v2.0, DICOM, or SPI (Standard Product Interconnect) or proprietary to the modality source vendor. The Olicon Gateway, converts the imaging or other data into DICOM, ACR-NEMA v2.0, SPI (Standard Product Interconnect) or proprietary data format and transmits the data to one or more user specified locations across a standard general purpose computing network. Typical users of this system are trained professionals, including but not limited to physicians, nurses and medical technicians.

Source page: https://510kreport.com/device/K973793
Methodology: https://510kreport.com/methodology