Aview Cac
by Coreline Soft Co., Ltd. 2 variants
510(k) K233211
Aview Cac is a medical device (FDA Class II; FDA product code QIH, Automated Radiological Image Processing Software) made by Coreline Soft Co., Ltd., cleared under FDA 510(k) K233211 on 29 Mar 2024, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK233211 | Date29 Mar 2024 | StatusActive |
Official records
- FDA 510(k) database K233211
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- QIH
- Device class
- Class II
- Regulation
- 21 CFR Part 892.2050
- Advisory committee
- Radiology
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K233211
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| AVIEW CAC 1.1 | 1.1 | 08800025300237 | — | On the market |
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