# K071584: Oasis Release 1.0

- Pathway: 510(k) (Traditional)
- Applicant: Segami Corporation
- Decided: Aug 31, 2007 after 81 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
No predicates in its family tree.
4 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K133654: Scenium (2014), 3 descendants of its own
- K150192: Scenium (2015), 2 descendants of its own
- K162339: Scenium (2016), 1 descendant of its own
- K173597: Scenium VE20 Software (2018), 0 descendants of its own

## Indications for use
The Oasis system is indicated for the processing and review of scintigraphy data and other related diagnostic medical images produced by DICOM-based multimodality sources. These sources may include, but are not limited to, radiological diagnostic systems, picture archival computers (PACS), and processing workstations. Oasis is capable of processing and displaying the medical image data in traditional formats, as well as in pseudo three-dimensional renderings, and in various forms of animated sequences, showing kinetic attributes of the imaged organs. The Oasis system displays the processed images using an integrated computer. Oasis provides manual and automatic report creation plus the ability to view these reports remotely. Oasis also provides patient scheduling tools. This device is not used in the primary diagnosis of Mammography images.

Source page: https://510kreport.com/device/K071584
Methodology: https://510kreport.com/methodology