FDA 510(k)
FDA class 2
Substantially Equivalent
🇰🇷 South Korea
AVIEW CAC
K Number: K233211
·
Decision Mar 29, 2024
Classifications
1
FEI Numbers
217
Registration Numbers
217
Same Product Code
303
Applicant Total
12
Review Days
183
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 CAC
- K Number
- K233211
- 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
- September 28, 2023
- Decision Date
- March 29, 2024
- Product Code
- QIH
- 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 |
|---|---|---|---|
| QIH | Automated Radiological Image Processing Software | FDA class 2 | Radiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (QIH), ordered by most recent decision date.
Synapse PACS (7.6.0)
FDA 510(k)
FDA Class 2
·Radiology
WatchMate Software
FDA 510(k)
FDA Class 2
·Radiology
MediAI-OA
FDA 510(k)
FDA Class 2
·Radiology
LungMaps
FDA 510(k)
FDA Class 2
·Radiology
Brainomix 360 Hyperdensity
FDA 510(k)
FDA Class 2
·Radiology
Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX)
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 |
| K221592 | AVIEW Lung Nodule CAD | Feb 24, 2023 | 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 |