3D Prostate Suite 3DTRUS Prostate Mapping, MRI/3DTRUS Fusion Option, Second Look 3DTRUS Fusion Option
FDA 510(k) K131448 · Koelis
510(k) numberK131448
Submission
- Device name
- 3D Prostate Suite 3DTRUS Prostate Mapping, MRI/3DTRUS Fusion Option, Second Look 3DTRUS Fusion Option
- Applicant
- Koelis
La Tronche, FR - Received
- May 20, 2013
- Decision date
- July 26, 2013
- 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 |
|---|---|---|
| K180970 | Disposable guides KDNG00ITX · Traditional | 07/10/2018SE |
| K171040 | Reusable guides ranges (PERINE range, NAIL range, CON-LEAD range and LIN-LEAD range) and…ITX · Traditional | 07/31/2017SE |
| K170521 | TRINITY/3D Prostate SuiteIYN · Traditional | 05/30/2017SE |
| K160357 | TrinityIYN · Traditional | 05/02/2016SE |
| K141334 | Reusable GuideITX · Traditional | 07/11/2014SE |
| K100793 | Urostation 3D Prostate SuiteLLZ · Traditional | 09/22/2010SE |
Questions and answers
When was 3D Prostate Suite 3DTRUS Prostate Mapping, MRI/3DTRUS Fusion Option, Second Look 3DTRUS Fusion Option cleared by the FDA?
3D Prostate Suite 3DTRUS Prostate Mapping, MRI/3DTRUS Fusion Option, Second Look 3DTRUS Fusion Option (K131448) received a 510(k) decision of Substantially Equivalent on July 26, 2013, 67 days after the submission was received.
What is the product code of K131448?
The FDA product code is LLZ – System, Image Processing, Radiological, a Class II (moderate risk) device regulated under 21 CFR 892.2050.