Lung-CAD
by Imagen Technologies, Inc. 2 variants
510(k) K230085
Lung-CAD is a medical device (FDA Class II; FDA product code MYN, Analyzer, Medical Image) made by Imagen Technologies, Inc., cleared under FDA 510(k) K230085 on 3 Oct 2023, active as of 10 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 | NumberK230085 | Date3 Oct 2023 | StatusActive |
Official records
- FDA 510(k) database K230085
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- MYN
- Device class
- Class II
- Regulation
- 21 CFR Part 892.2070
- Advisory committee
- Radiology
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K230085
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 | |||
|---|---|---|---|---|
| ChestSuite 1.0.0 | 1.0.0 | 00852491008047 | — | On the market |
Similar devices
Other devices filed under FDA product code MYN (Analyzer, Medical Image).
- Second Opinion CC Analyzer by Pearl, Inc.
- Overjet Caries Assist by OVERJET
- M-VU Algorithm Engine by Icad, Inc.
- Velmeni for Dentists (V4D) Endo-Perio by VELMENI Inc.
- Better Diagnostics Dental Assist (BDDA) Version 1.0 by BETTER DIAGNOSTICS AI CORP
- ChestView US (1.1) by GLEAMER
- Overjet Calculus Assist by OVERJET
- PowerLook Tomo Detection Software by Icad, Inc.
- RAPIDSCREEN RS-2000D by Riverain Medical Group
- DTX Studio Assist by Nobel Biocare C/O Medicim NV