Dsa 2000EX
FDA 510(k) K082341 · Eigen, LLC
510(k) numberK082341
Submission
- Device name
- Dsa 2000EX
- Applicant
- Eigen, LLC
Grass Valley, CA, US - Received
- August 15, 2008
- Decision date
- August 29, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
Other 510(k)s with product code LLZ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
| K261916 | NeuroQuant PETLLZ · Traditional | Cortechs Labs, Inc. | 08/12/2026SE |
| K260936 | RadioViewAILLZ · Traditional | Neurocareai, Inc. (Dba Savelife.Ai) | 07/31/2026SE |
| 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 |
|---|---|---|
| K222222 | Artemis, Artemis TPO, Artemis MXQTZ · Traditional | 10/12/2023SE |
| K173744 | ProFuse CADLLZ · Traditional | 11/21/2018SE |
| K162474 | ArtemisLLZ · Traditional | 10/21/2016SE |
| K081093 | 3-D Imaging WorkstationLLZ · Traditional | 05/01/2008SE |
| K063846 | Eigen Dsa 2000LLZ · Special | 01/26/2007SE |
| K933115 | Digital Disk RecorderLMB · Traditional | 04/07/1994SE |
| K924164 | Digital Disk Recorder W/Dualpath ARCHIVE/30-60 OptJAA · Traditional | 11/23/1992SE |
| K923585 | Digital Fluoro StoreJAA · Traditional | 10/21/1992SE |
| K913012 | Digital Fluoro Store(Dfs) W/Numerical SuffixesJAA · Traditional | 09/23/1991SE |
| K905111 | Digital Disk Recorder(Ddr) W/Numerical SuffixesJAA · Traditional | 01/25/1991SE |
Questions and answers
When was Dsa 2000EX cleared by the FDA?
Dsa 2000EX (K082341) received a 510(k) decision of Substantially Equivalent on August 29, 2008, 14 days after the submission was received.
What is the product code of K082341?
The FDA product code is LLZ – System, Image Processing, Radiological, a Class II (moderate risk) device regulated under 21 CFR 892.2050.