Identifiers
- 510(k) Number
- K220408 FDA 510(k)
- FDA Product Code
- QKB 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)
AVIEW RT ACS is a radiological image processing software designed for radiation therapy. It automates the segmentation of organs using deep-learning algorithms, generating RT-DICOM formatted contours from CT images. These contours serve as initial reference masks for radiation oncology professionals to review, edit, and integrate into treatment planning workflows. The device aids in streamlining the contouring process for precise radiation therapy delivery.
The AVIEW RT ACS is supplied as a software solution for use in radiation oncology departments. It operates on a non-sterile, reusable digital platform and requires no specific MRI safety considerations. The software is intended for institutional use, with no explicit size or storage requirements beyond standard IT infrastructure. Authorisations include FDA 510(k) clearance, compliance with the Medical Device Directive (MDD), and the Medical Device Regulation (MDR).
Frequently asked questions
What is the primary purpose of the AVIEW RT ACS software in radiation therapy workflows?
The AVIEW RT ACS automates the segmentation of organs in CT images using deep-learning algorithms, generating RT-DICOM formatted contours. These serve as initial reference masks that radiation oncology professionals can review, edit, and integrate into their treatment planning workflows, helping to streamline and improve the precision of radiation therapy delivery.
How is the AVIEW RT ACS supplied, and does it require any special handling or storage conditions?
The AVIEW RT ACS is supplied as a software solution for institutional use on a digital platform. Since it is non-sterile and reusable, no special handling or storage conditions are required beyond standard IT infrastructure. It does not involve physical devices or consumables, so typical IT storage and maintenance protocols apply.
Is the AVIEW RT ACS intended for single-use or repeated use across multiple patients, and what are its regulatory approvals?
The AVIEW RT ACS is designed for repeated institutional use, as it operates on a reusable digital platform. It holds FDA 510(k) clearance, compliance with the Medical Device Directive (MDD), and the Medical Device Regulation (MDR), ensuring it meets regulatory standards for radiological image processing software in radiation therapy.
Does the AVIEW RT ACS have any specific safety considerations, such as MRI compatibility or physical size requirements?
The AVIEW RT ACS does not require any MRI safety considerations, as it is a software-based solution with no physical components. There are no explicit size or storage requirements beyond standard IT infrastructure, making it adaptable to most radiation oncology departments.
What types of institutions or departments would benefit most from using the AVIEW RT ACS?
The AVIEW RT ACS is specifically designed for radiation oncology departments within hospitals or clinics. Its automated contouring capabilities help streamline workflows, making it particularly useful for institutions treating large volumes of patients or those seeking to improve efficiency in radiation therapy planning.
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: All aview Software - Coreline Soft, aview:RT ACS - Coreline Soft - healthairegister.com, About Coreline Soft | Advancing Radiology with AI, AVIEW RT ACS Review: Pricing, FDA Status & Alternatives | Physician AI ...
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Active |
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K220408 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Coreline Soft Co., Ltd.
Sources (2)
- FDA 510(k) K220408 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026