Olea S.I.A V1.0
Let the assistant research this device
The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.
Free to try · every answer cites its records
Basic Information
- Brand Name
- Olea S.I.A V1.0
- Primary DI
- EOLEOLEASIAV1P00
- Version / Model
- 1.0
- Company Name
- Olea Medical USA
- Labeler DUNS
- 047358761
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-11-22
- Public Version
- 2
- Public Version Date
- 2023-10-18
- Public Version Status
- Update
- Public Device Record Key
- 2e947a50-b7d0-43b4-b64a-8949e605fd6e
Device Description
Olea S.I.A V1.0 is a medical image communications device that provides electronic transfer of medical image data between medical devices. Olea S.I.A V1.0 stores, converts formats and displays medical device data. Olea S.I.A V1.0 allows the integration of separately registered or cleared processing applications owned by Olea Medical or third parties. These applications are not part of the platform itself. Olea S.I.A V1.0 allows routing DICOM-compliant and non-DICOM-compliant image data to and from integrated processing applications. For DICOM-compliant image data, Olea S.I.A V1.0 reads DICOM tags and pixel data to label images. Olea S.I.A V1.0 allows the integrated processing applications to provide a notification or a flag intended to the user about the status of its outputs. Olea S.I.A V1.0 provides a simple image software review functionality for medical image processing and manipulation, such as grayscale window and level, zoom and pan. Olea S.I.A V1.0 is intended to be used by trained professionals. Olea S.I.A V1.0 is not intended for primary diagnosis, detailed treatment planning or treatment of patients and shall not be used to take decisions with diagnosis or therapeutic purposes.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LMD | System, Digital Image Communications, Radiological | Radiology | 892.2020 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 41670 | Radiological PACS software | An individual software application intended to be installed on a central server as part of a picture archiving and communication system (PACS) to allow storage, retrieval, analysis, and management of radiological images. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | EOLEOLEASIAV1P00 | HIBCC |