Identifiers
- 510(k) Number
- K083491 FDA 510(k)
- FDA Product Code
- LLZ FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.2050 FDA 510(k)
- Regulation Number
- 892.2050 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Neuroscape is a medical device used in radiology, specifically a Class II X-ray system. It is designed to provide precise results and clear image interpretation for effective patient treatment. The device is a neuro-oncology solution that offers a range of innovative functions.
The Neuroscape is supplied as a single device and is cleared under FDA 510K with the K-number K083491. It is intended for use in a radiology setting and has been authorized by the FDA. The device is manufactured by Olea Medical and has a specific product code of LLZ.
Frequently asked questions
What is the Neuroscape used for?
The Neuroscape is used in radiology for neuro-oncology, providing precise results and clear image interpretation for effective patient treatment.
Is the Neuroscape cleared by the FDA?
Yes, the Neuroscape is cleared under FDA 510K with the K-number K083491, indicating it has been found to be substantially equivalent to a predicate device.
How is the Neuroscape supplied?
The Neuroscape is supplied as a single device, intended for use in a radiology setting.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Olea Medical: medical diagnosis software, Neuroimaging: neuro-oncology solution - Olea Medical, Olea Neuroscape - allmed.wiki
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K083491 | Class II | Active |
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Manufacturer
- Manufacturer
- Olea Medical
Sources (1)
- FDA 510(k) K083491 24 fields · synced Sep 22, 2026