EConsole2
510(k) K240243
EConsole2 is a Class II device made by DRTECH Corporation, cleared under FDA 510(k) K240243 on 23 Sep 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 | NumberK240243 | Date23 Sep 2024 | StatusActive |
Official records
- FDA 510(k) database K240243
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- Withdrawn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
Devices cleared under K240243
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 | |||
|---|---|---|---|---|
| EConsole2 | EConsole2 | 08800018412008 | — | On the market |
Similar devices
Other devices filed under FDA product code LLZ (System, Image Processing, Radiological).
- maiLink by Maihub Corp.
- Veuron-Brain-pAb2 by Heuron Co., Ltd.
- AnatomicAligner by The Methodist Hospital Research Institute D/B/A Houston
- SPY ANALYSIS TOOLKIT, MODEL SA9000 by Novadaq Technologies Inc
- ASCEND Image Viewer by Ascend Hit
- CT BRAIN PERFUSION FOR ZIOSTATION by ZIOSOFT, INC.
- DFS-700 by Shimadzu Corp.
- IMPAX Agility by Agfa Healthcare N.V.
- CDP 5000, MEDIA AND DISTRIBUTION CENTER, DIAGNET by Cdp, Ltd.
- AIBOLIT 3D+ by Aibolit Technologies, LLC