# Coreline Soft Co., Ltd.

- Location (FDA's records): Seoul, KR
- FDA decisions: 13 (2018–2026): 13 510(k) clearances
- Product codes: LLZ (5), QIH (4), OEB (2), QKB (1), JAK (1)
- 510(k) review time since 2016: median 175 days, against 138 for FDA's reviews in the same codes and years (2 of 12 faster)
- Predicates its devices cite: 12 (7 its own); citations of its devices by later devices: 9 (7 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Siemens Healthcare GmbH: 1 (https://510kreport.com/company/siemens-healthcare)
- 3D Systems, Inc.: 1 (https://510kreport.com/company/3d-systems)
- Philips Medical Systems Nederland B.V.: 1 (https://510kreport.com/company/philips-medical-systems-nederland)
- Vital Images, Inc.: 1 (https://510kreport.com/company/vital-images)
- Mim Software, Inc.: 1 (https://510kreport.com/company/mim-software)

## Firms that cite its devices most
- Terarecon,Inc.: 1 (https://510kreport.com/company/terarecon)
- V5med, Inc.: 1 (https://510kreport.com/company/v5med)

## Its most-cited devices
- K221592: AVIEW Lung Nodule CAD (2023), cited by 2
- K214036: AVIEW (2022), cited by 2
- K233211: Aview Cac (2024), cited by 2
- K200714: AVIEW (2020), cited by 1
- K193220: Aview LCS (2020), cited by 1
- K171199: AVIEW (2018), cited by 1

## Recent decisions
- K260391: AVIEW Aorta Metrics (Oct 16, 2026)
- K251203: AVIEW Lung Nodule CAD (Dec 3, 2025)
- K243689: AVIEW (Mar 19, 2025)
- K243696: Aview Cac (Feb 14, 2025)
- K233211: Aview Cac (Mar 29, 2024)
- K221592: AVIEW Lung Nodule CAD (Feb 24, 2023)
- K214036: AVIEW (Dec 23, 2022)
- K220408: Aview RT Acs (Nov 10, 2022)

Source page: https://510kreport.com/company/coreline-soft