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Olea S.I.A. Neurovascular

FDA UDI

Class II (US FDA UDI)

by Olea Medical USA

Identity

Trade Name
Olea S.I.A. Neurovascular FDA UDI
Generic Name
Radiological PACS software FDA UDI
Device Name
Olea S.I.A. Neurovascular V1.0 is an optional user interface for use on the Olea Medical technical integration platform Olea S.I.A. V1.0 and is designed to be used by trained professionals with medical imaging education including, but not limited to, physicians and medical technicians. Olea S.I.A. Neurovascular V1.0 is intended to: • display MR and CT series and outputs provided by compatible docker applications processing, through the technical integration platform, • allow the user to edit and modify parameters that are optional inputs of aforementioned applications. These modified parameters are provided through the technical integration platform as inputs to the docker application to reprocess outputs. When available, Olea S.I.A. Neurovascular V1.0 display can be updated with the reprocessed outputs. The information displayed is intended to be used in conjunction with other patient information and based on professional judgment, to assist the clinician in the medical imaging assessment. It is not intended to be used in lieu of the standard care imaging. Trained professionals are responsible for viewing the full set of native images per the standard of care. FDA UDI
Model / Reference
V1.0 FDA UDI
Description
Olea S.I.A. Neurovascular V1.0 is an optional user interface for use on the Olea Medical technical integration platform Olea S.I.A. V1.0 and is designed to be used by trained professionals with medical imaging education including, but not limited to, physicians and medical technicians. Olea S.I.A. Neurovascular V1.0 is intended to: • display MR and CT series and outputs provided by compatible docker applications processing, through the technical integration platform, • allow the user to edit and modify parameters that are optional inputs of aforementioned applications. These modified parameters are provided through the technical integration platform as inputs to the docker application to reprocess outputs. When available, Olea S.I.A. Neurovascular V1.0 display can be updated with the reprocessed outputs. The information displayed is intended to be used in conjunction with other patient information and based on professional judgment, to assist the clinician in the medical imaging assessment. It is not intended to be used in lieu of the standard care imaging. Trained professionals are responsible for viewing the full set of native images per the standard of care. FDA UDI

Identifiers

Primary DI / UDI-DI
EOLENEUROVASV1P00 FDA UDI
510(k) Number
K223532 FDA UDI
FDA Product Code
LLZ FDA UDI
GMDN Term
Radiological PACS software FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
892.2050 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Radiological PACS software

Olea S.I.A. Neurovascular by Olea Medical USA — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Radiological PACS software.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Olea Medical USA

Sources (1)

  • FDA UDI e265d750-cb4c-4a03-8002-e23bcde1a62f 35 fields · synced May 30, 2026