Oasis - Oasis is a software product designed to operate - SEGAMI CORPORATION

Duns Number:937692440

Device Description: Oasis is a software product designed to operate on an office PC. The product is intended f Oasis is a software product designed to operate on an office PC. The product is intended for use by qualified medical personnel for the assessment of diagnostic medical images.The software allows for the processing, review, and transfer of scintigraphy camera output data as well as 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 acquired information 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 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.The Oasis product is not intended to be used as a replacement for visual interpretation, nor as a diagnostic tool without the use of other clinical and laboratory information.

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More Product Details

Catalog Number

-

Brand Name

Oasis

Version/Model Number

V1

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K071584

Product Code Details

Product Code

LLZ

Product Code Name

System, Image Processing, Radiological

Device Record Status

Public Device Record Key

093653bc-7131-493a-abb5-98c3f48d9e23

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

March 11, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SEGAMI CORPORATION" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 1