Aview Lcs
510(k) K193220
Active
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK193220 | Date5 May 2020 | StatusActive |
Official records
- FDA 510(k) database K193220
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- LLZ
- Device class
- Class II
- Regulation
- 21 CFR Part 892.2050
- Advisory committee
- Radiology
- FDA decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 26 Sep 2026
Aview Lcs is a software device designed for the review, analysis, and reporting of thoracic CT images. It assists healthcare professionals by characterizing lung nodules, including their type, location, and measurements such as major axis, minor axis, and estimated effective diameter.
This device supports the review of analysis information within the interpretation environment, including Worklist, GSPS, and Report. It is authorized via FDA 510k clearance under K193220.
Devices cleared under K193220
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 LCS 1.0 | 1.0 | 08800025300039 | — | On the market |
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