Aview RT Acs
FDA 510(k) K220408 · Coreline Soft Co., Ltd.
510(k) numberK220408
Submission
- Device name
- Aview RT Acs
- Applicant
- Coreline Soft Co., Ltd.
Seoul, KR - Received
- February 14, 2022
- Decision date
- November 10, 2022
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- QKB – Radiological Image Processing Software For Radiation Therapy
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 892.2050
- Specialty
- Radiology
To provide semi-automatic or fully-automated radiological image processing and analysis tools for radiation therapy. Software implementing artificial intelligence (AI) including nonadaptive machine learning algorithms trained with clinical and/or artificial radiological images. In these devices, the algorithm training images typically impact device performance. AI based radiological image…
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| K243696 | Aview CacQIH · Special | 02/14/2025SE |
| K233211 | Aview CacQIH · Traditional | 03/29/2024SE |
| K221592 | AVIEW Lung Nodule CADOEB · Traditional | 02/24/2023SE |
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| K201710 | A View LCSLLZ · Traditional | 10/16/2020SE |
| K200714 | AviewLLZ · Traditional | 08/26/2020SE |
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Questions and answers
When was Aview RT Acs cleared by the FDA?
Aview RT Acs (K220408) received a 510(k) decision of Substantially Equivalent on November 10, 2022, 269 days after the submission was received.
What is the product code of K220408?
The FDA product code is QKB – Radiological Image Processing Software For Radiation Therapy, a Class II (moderate risk) device regulated under 21 CFR 892.2050.