FDA 510(k)
FDA class 2
Substantially Equivalent
🇰🇷 South Korea
AVIEW Lung Nodule CAD
K Number: K221592
·
Decision Feb 24, 2023
Classifications
1
FEI Numbers
11
Registration Numbers
11
Same Product Code
19
Applicant Total
12
Review Days
267
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- AVIEW Lung Nodule CAD
- K Number
- K221592
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.2050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Coreline Soft Co., Ltd.
- Date Received
- June 2, 2022
- Decision Date
- February 24, 2023
- Product Code
- OEB
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| OEB | Lung Computed Tomography System, Computer-Aided Detection | FDA class 2 | Radiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (OEB), ordered by most recent decision date.
Synapse Lung Nodule AI
FDA 510(k)
FDA Class 2
·Radiology
AVIEW Lung Nodule CAD
FDA 510(k)
FDA Class 2
·Radiology
InferRead Lung CT.AI
FDA 510(k)
FDA Class 2
·Radiology
V5med Lung AI
FDA 510(k)
FDA Class 2
·Radiology
syngo.CT Lung CAD (Version VD30)
FDA 510(k)
FDA Class 2
·Radiology
ClearRead CT
FDA 510(k)
FDA Class 2
·Radiology
Other Clearances by Coreline Soft Co., Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K251203 | AVIEW Lung Nodule CAD | Dec 3, 2025 | Substantially Equivalent |
| K243689 | AVIEW | Mar 19, 2025 | Substantially Equivalent |
| K243696 | AVIEW CAC | Feb 14, 2025 | Substantially Equivalent |
| K233211 | AVIEW CAC | Mar 29, 2024 | Substantially Equivalent |
| K214036 | AVIEW | Dec 23, 2022 | Substantially Equivalent |
| K220408 | AVIEW RT ACS | Nov 10, 2022 | Substantially Equivalent |
| K201710 | A View LCS | Oct 16, 2020 | Substantially Equivalent |
| K200714 | AVIEW | Aug 26, 2020 | Substantially Equivalent |
| K193220 | AVIEW LCS | May 5, 2020 | Substantially Equivalent |
| K192040 | AVIEW Modeler | Dec 20, 2019 | Substantially Equivalent |