EConsole1
FDA 510(k) K231225 · DRTECH Corporation
510(k) numberK231225
Submission
- Device name
- EConsole1
- Applicant
- DRTECH Corporation
Seongnam-Si, KR - Received
- April 28, 2023
- Decision date
- October 18, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code LLZ
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| K262060 | 3D-RD-SLLZ · Traditional | Radiopharmaceutical Imaging & Dosimetry, LLC | 09/04/2026SE |
| K261500 | KBA3D (v2.4.0)LLZ · Traditional | S.M.A.I.O | 08/17/2026SE |
| K262449 | AdvaViewLLZ · Special | Advahealth Solutions, LLC | 08/14/2026SE |
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| K260588 | Cleerly LABSLLZ · Traditional | Cleerly, Inc. | 07/29/2026SE |
| K262462 | TheraSphere 360 Y-90 Management PlatformLLZ · Special | Boston Scientific Corporation | 07/24/2026SE |
| K262143 | ImageGrid StreamVueLLZ · Traditional | Candelis, Inc. | 07/23/2026SE |
| K260500 | ResolutionMDLLZ · Traditional | ResolutionMD, Inc. | 07/21/2026SE |
| K262120 | Avara ViewerLLZ · Traditional | Avara Software | 07/10/2026SE |
More from Avara Software
| 510(k) | Device | Decision |
|---|---|---|
| K260227 | EXSYS DEXi (EXSYS DEXi-S40S); EXSYS DEXi (EXSYS DEXi-S40P); EXSYS DEXi (EXSYS…KPR · Traditional | 09/08/2026SE |
| K261413 | Extron 3;EXTRON 6OWB · Traditional | 08/19/2026SE |
| K250010 | Extron 3; Extron 5; Extron 7OWB · Traditional | 06/10/2025SE |
| K242770 | Expd 114; Expd 114G; Expd 114P; Expd 114PGMQB · Special | 03/20/2025SE |
| K243443 | Expd 4343N1; Expd 4343N; Expd 4343U1; Expd 4343NU; Expd 4343NP; Expd 3643N1; Expd 3643N…MQB · Special | 03/19/2025SE |
| K242591 | XERO-alphaEHD · Traditional | 11/01/2024SE |
| K242847 | EXSYS DEXi (EXSYS DEXi-D401S-FRM); EXSYS DEXi (EXSYS DEXi-A401S-FRM); EXSYS DEXi (EXSYS…KPR · Special | 10/23/2024SE |
| K240243 | EConsole2LLZ · Traditional | 09/23/2024SE |
| K233530 | EXSYS DEXi (EXSYS DEXi-D401S-FRM); EXSYS DEXi (EXSYS DEXi-A401S-FRM); EXSYS DEXi (EXSYS…KPR · Traditional | 07/26/2024SE |
| K232082 | Expd 4343SMQB · Special | 02/13/2024SE |
Questions and answers
When was EConsole1 cleared by the FDA?
EConsole1 (K231225) received a 510(k) decision of Substantially Equivalent on October 18, 2023, 173 days after the submission was received.
What is the product code of K231225?
The FDA product code is LLZ – System, Image Processing, Radiological, a Class II (moderate risk) device regulated under 21 CFR 892.2050.