OLEA SPHERE

GUDID EOLEOLEASPHEREV3P01

Olea Sphere V3.0 is an image processing software package to be used by trained professionals including but not limited to physicians and medical technicians. The software runs on a standard "off-the-shelf" workstation and can be used to perform image viewing, processing, image collage and analysis of medical images. Data and images are acquired through DICOM compliant imaging devices and modalities.

Olea Medical USA

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• Primary Device ID: EOLEOLEASPHEREV3P01
• NIH Device Record Key: e79b38ae-ff4c-4771-ae73-225b5b9c8f3b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OLEA SPHERE
• Version Model Number: 3.0
• Company DUNS: 047358761
• Company Name: Olea Medical USA
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1 617 354 0721
• Email: contact@olea-medical.com
• Phone: +1 617 354 0721
• Email: contact@olea-medical.com
• Phone: +1 617 354 0721
• Email: contact@olea-medical.com
• Phone: +1 617 354 0721
• Email: contact@olea-medical.com
• Phone: +1 617 354 0721
• Email: contact@olea-medical.com
• Phone: +1 617 354 0721
• Email: contact@olea-medical.com
• Phone: +1 617 354 0721
• Email: contact@olea-medical.com
• Phone: +1 617 354 0721
• Email: contact@olea-medical.com
• Phone: +1 617 354 0721
• Email: contact@olea-medical.com
• Phone: +1 617 354 0721
• Email: contact@olea-medical.com
• Phone: +1 617 354 0721
• Email: contact@olea-medical.com
• Phone: +1 617 354 0721
• Email: contact@olea-medical.com
• Phone: +1 617 354 0721
• Email: contact@olea-medical.com
• Phone: +1 617 354 0721
• Email: contact@olea-medical.com
• Phone: +1 617 354 0721
• Email: contact@olea-medical.com
• Phone: +1 617 354 0721
• Email: contact@olea-medical.com
• Phone: +1 617 354 0721
• Email: contact@olea-medical.com
• Phone: +1 617 354 0721
• Email: contact@olea-medical.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	EOLEOLEASPHEREV3P01 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K152602

FDA Product Code

• LLZ: System, Image Processing, Radiological

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-05-23
• Device Publish Date: 2016-09-22

On-Brand Devices [OLEA SPHERE]

• EOLEOLEASPHEREV3P01: Olea Sphere V3.0 is an image processing software package to be used by trained professionals inc
• EOLEOLEASPHEREV2P31: Olea Sphere V2.3 is an image processing software package to be used by trained professionals inc