Oasis

Primary DI
00857198006006
Brand
Oasis
Company
SEGAMI CORPORATION
Model
V1
Device description
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.
Published
2016-03-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
LLZSystem, Image Processing, Radiological

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LLZSystem, Image Processing, RadiologicalRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K071584000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K071584000OASIS RELEASE 1.0Segami Corporation2007-08-31LLZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00857198006006PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00857198006006008571980060068571980060060857198006006

GMDN Terms#

Term, Definition table
TermDefinition
Gamma camera system application softwareAn individual software program or group of programs, routines or algorithms that add specific image processing and/or analysis capabilities to a gamma camera-based imaging system configuration. A basic set of applications programs and routines are included with such computer-controlled imaging systems and can be upgraded to correct programming errors or to add new system capabilities. Some must be used with specific configurations to function as intended. Applications program packages are typically identified by a proprietary name and "version" or "upgrade" number.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
937692440
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00857198006013OasisV32024-03-11

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