CSV12 Software Viewer
FDA 510(k) K022896 · Acuson Corp.
510(k) numberK022896
Submission
- Device name
- CSV12 Software Viewer
- Applicant
- Acuson Corp.
Mountain View, CA, US - Received
- September 3, 2002
- Decision date
- October 3, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
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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 |
| 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
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| K021497 | Cypress Ultrasound SystemIYN · Special | 07/09/2002SE |
| K010950 | Cypress SystemIYO · Abbreviated | 06/27/2001SE |
| K002807 | 3D Organ Assessment W/ Magnetic Position SensingIYO · Traditional | 12/01/2000SE |
| K992631 | Acunav Diagnostic Ultrasound CatheterDQO · Traditional | 12/15/1999SE |
| K992580 | Fetal Assessment CapIYO · Traditional | 10/18/1999SE |
| K991805 | Aspen Ultrasound with Freestyle Imaging OptionIYN · Traditional | 08/02/1999SE |
| K973767 | Harmonic Imaging with ContrastIYO · Traditional | 12/23/1997SE |
| K973079 | L7 Transducer Used on Aspen Model Ultrasound SystemITX · Traditional | 11/05/1997SE |
Questions and answers
When was CSV12 Software Viewer cleared by the FDA?
CSV12 Software Viewer (K022896) received a 510(k) decision of Substantially Equivalent on October 3, 2002, 30 days after the submission was received.
What is the product code of K022896?
The FDA product code is LLZ – System, Image Processing, Radiological, a Class II (moderate risk) device regulated under 21 CFR 892.2050.