OASIS RELEASE 1.0
SEGAMI CORPORATION
SEGAMI CORPORATION
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3003370689 | 3003370689 | SEGAMI CORPORATION | 1 | N | 2026-01-01 | 8310 Guilford Rd Ste A COLUMBIA MD US 21046 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 58830 | 1333376215 | K071584 | OASIS RELEASE 1.0 | LLZ | 2007-08-31 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| LLZ | 1 | 2007-08-31 |
PMN#
DGSCOPE, RELEASE 1.0
SEGAMI CORPORATION
MIRAGE CEDARS OPTION
SEGAMI CORPORATION
MIRAGE, RELEASE 5.5
SEGAMI CORPORATION
MODIFICATION TO MIRAGE
SEGAMI CORP., INC.
MIRAGE
SEGAMI CORP., INC.
GUDID#
Oasis - Oasis is a SaMD (Software as a Medical Device). It 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 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. 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 automatic and manual 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 is a software-only medical device (a SaMD). Oasis does not directly or indirectly control any medical device that has contact with the user or patient. Oasis does not automate the diagnosis of a patient in any way. Oasis does not come into contact with patients and does not contain medicinal substances or non-viable animal/human tissues.
2024-03-11
Oasis - 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.
2016-03-11