Rayvolve PTX-PE
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
by AZmed
Identifiers
- 510(k) Number
- K243808 FDA 510(k)
- FDA Product Code
- QFM FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.2080 FDA 510(k)
- Regulation Number
- 892.2080 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Rayvolve PTX-PE is a Radiological Computer-Assisted Prioritization Software for Lesions, designed to assist radiologists in evaluating and prioritising pulmonary nodules and other lesions within chest imaging studies. This Class II device leverages AI-driven algorithms to enhance diagnostic workflows by identifying and stratifying findings based on predefined risk criteria, thereby supporting more efficient and standardised assessments in radiology.
Supplied as a software application, the Rayvolve PTX-PE operates within a clinical radiology setting and is intended for single-use per imaging session, though its software licence may allow repeated use across multiple studies. Authorised under FDA 510(k) and MDR, it adheres to regulatory standards for medical imaging software, with no specific sterility or reusable components. The device is non-invasive, MRI-safe, and does not require physical storage beyond the facility’s IT infrastructure. Its registration numbers include multiple FEI identifiers (e.g., 3034205378) under the QFM product code, reflecting its classification as a diagnostic imaging aid.
Frequently asked questions
What specific types of chest imaging studies does the Rayvolve PTX-PE assist with in evaluating pulmonary nodules and lesions?
The Rayvolve PTX-PE is designed to assist radiologists in evaluating pulmonary nodules and other lesions within chest imaging studies, but the exact imaging modalities (e.g., CT, X-ray) are not specified. It leverages AI-driven algorithms to prioritize findings based on predefined risk criteria, supporting standardized assessments in radiology workflows for these types of studies.
Is the Rayvolve PTX-PE software intended for repeated use across multiple imaging sessions, or is it single-use per session?
The Rayvolve PTX-PE is intended for single-use per imaging session, though its software license allows for repeated use across multiple studies. This means the software itself can be utilized for various sessions, but its application to a specific imaging session is considered a single-use instance for prioritization and evaluation purposes.
Does the Rayvolve PTX-PE require any special storage conditions or physical infrastructure beyond standard IT systems?
No, the Rayvolve PTX-PE does not require physical storage beyond the facility’s existing IT infrastructure. Since it is a software application, it operates within the radiology department’s digital environment and does not involve any hardware or specialized storage requirements.
What regulatory pathways does the Rayvolve PTX-PE follow, and how does this affect its use in clinical settings?
The Rayvolve PTX-PE is authorized under both FDA 510(k) and MDR (Medical Device Regulation) pathways, confirming its compliance with regulatory standards for medical imaging software. This means it has undergone evaluation to ensure safety and effectiveness, allowing its use in clinical radiology settings for assisting in the prioritization of pulmonary nodules and lesions as intended.
Are there any physical components of the Rayvolve PTX-PE that require sterilization or reuse considerations?
The Rayvolve PTX-PE is a software-only solution with no physical components, so there are no sterility or reusable parts to consider. Its non-invasive and MRI-safe nature further confirms it operates purely within digital systems without requiring physical handling or maintenance beyond standard IT practices.
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.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K243808 | Class II | Active |
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Manufacturer
- Manufacturer
- AZmed
Sources (2)
- FDA 510(k) K243808 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 29, 2026