Kavo Ergocom/Ergocam
FDA 510(k) K050744 · Kavo America Corporation
510(k) numberK050744
Submission
- Device name
- Kavo Ergocom/Ergocam
- Applicant
- Kavo America Corporation
Deer Field, IL, US - Received
- March 22, 2005
- Decision date
- April 21, 2005
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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 |
|---|---|---|
| K073074 | Key Laser III 1243 US with DetectGEX · Special | 07/10/2008SE |
| K072262 | Gentleray 980 Diode Laser SystemGEX · Traditional | 10/26/2007SE |
| K063624 | Kavo Everest C-TempEBG · Traditional | 02/08/2007SE |
| K051909 | DiagnodentNBL · Traditional | 10/21/2005SE |
| K030146 | Kavo Key Laser 1242 and Kavo Key Laser 1243+NVK · Traditional | 08/03/2005SE |
| K042394 | Diagnodent Perio Tip (Accessory)NBL · Traditional | 08/02/2005SE |
| K050019 | In Exam Intraoral Dental X-Ray SystemEHD · Traditional | 01/31/2005SE |
| K042872 | Rondoflex Plus 360KOJ · Special | 11/23/2004SE |
| K033221 | Kavo Everest Zh-BlankEIH · Special | 10/28/2003SE |
| K032081 | Kavo Everest Zs-Blank Models, 42, 20, and 60EIH · Special | 07/24/2003SE |
Questions and answers
When was Kavo Ergocom/Ergocam cleared by the FDA?
Kavo Ergocom/Ergocam (K050744) received a 510(k) decision of Substantially Equivalent on April 21, 2005, 30 days after the submission was received.
What is the product code of K050744?
The FDA product code is LLZ – System, Image Processing, Radiological, a Class II (moderate risk) device regulated under 21 CFR 892.2050.