AVIEW RT ACS
K220408Coreline Soft Co.,Ltd · cleared 2022-11-10 · product code QKB · Radiology
Premarket evidence — what FDA accepted
source quote (p.5)
“The 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.”
source quote (p.5)
“The AVIEW RT ACS provides deep-learning-based auto-segmented organs and generates contours in RT-DICOM format from CT images.”
Validation studies (1)
Reader study (MRMC)
n=120 cases · 3 site(s)
endpoints: DSC; 95% HD
Reported performance (1 observation)
source quote (p.10)
“Brain (25) 0.97 ± 0.01(0.97, 0.98)”
Each value carries its own analysis unit and task — never compare or pool across devices. Source: 510(k) summary PDF.
Predicate network
Postmarket — what happened after clearance
- re_clearance
The FDA AI/ML device list shows a newer 510(k) K243689 (decision 2025-03-19) from Coreline Soft Co., Ltd. for a matching device line ("AVIEW") — a new clearance for the same line is a change event.
first seen 2026-07-08 · k_number:K243689
- re_clearance
The FDA AI/ML device list shows a newer 510(k) K214036 (decision 2022-12-23) from Coreline Soft Co.,Ltd. for a matching device line ("AVIEW") — a new clearance for the same line is a change event.
first seen 2026-07-08 · k_number:K214036
Recall and MAUDE counts are product-code-level (reports aren't reliably attributable to one device). Signals are descriptive observables with sources — never a judgment that the device is unsafe or drifting. Snapshot 2026-07-08.
Reimbursement — how devices like this got paid
Not yet tracked — no payment pathway indexed for this clearance (the reimbursement corpus is a growing seed set).