# K220408: Aview RT Acs

- Pathway: 510(k) (Traditional)
- Applicant: Coreline Soft Co., Ltd.
- Decided: Nov 10, 2022 after 269 days
- Product code: QKB (Radiological Image Processing Software For Radiation Therapy)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 14 generations back to K954874 (1996). 100 ancestors in all.
No later device cites it as a predicate yet.
1 of 101 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K182624: MIM - MRT Dosimetry, Mim Software, Inc. (2018) Summary page 4.

## Indications for use
AVIEW RT ACS provides deep-learning-based auto-segmented organs and generates contours in RT-DICOM format from CT images which could be used as an initial contour for the clinicians to approve and edit by the radiation oncology department for treatment planning or other professions where a segmented mask of organs is needed. a. Deep learning contouring from four body parts (Head & Neck, Breast, Abdomen, and Pelvis) b. Generates RT-DICOM structure of contoured organs c. Rule-based auto pre-processing Receive/Send/Export medical images and DICOM data Note that the Breast (Both right and left lung, Heart) were validated with non-contrast and contrast CT. Head & Neck (Both right and left Eyes, Brain and Mandible), Abdomen (Both right and left Kidney and Liver), and Pelvis (Both right and left Femur and Bladder) were validated with Contrast CT only.

Source page: https://510kreport.com/device/K220408
Methodology: https://510kreport.com/methodology