AI-Rad Companion Prostate MR
FDA 510(k) K252608 · Siemens Healthcare GmbH
510(k) numberK252608
Submission
- Device name
- AI-Rad Companion Prostate MR
- Applicant
- Siemens Healthcare GmbH
Erlanger, DE - Received
- August 18, 2025
- Decision date
- September 9, 2025
- 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 |
|---|---|---|
| K253264 | myAblation Guide (VC10A)QTZ · Traditional | 06/16/2026SE |
| K253689 | syngo Dynamics (VA41F)QIH · Traditional | 04/10/2026SE |
| K252548 | AI-Rad Companion Organs RTQKB · Traditional | 04/10/2026SE |
| K253057 | AI-Rad Companion Brain MRQIH · Traditional | 01/22/2026SE |
| K252838 | MAGNETOM Sola; MAGNETOM Altea; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile; MAGNETOM Vida…LNH · Traditional | 12/19/2025SE |
| K250443 | MAGNETOM Avanto Fit; MAGNETOM Skyra Fit; MAGNETOM Sola Fit; MAGNETOM Viato.MobileLNH · Traditional | 06/16/2025SE |
| K242551 | syngo Dynamics (Version VA41D)QIH · Traditional | 04/03/2025SE |
| K242745 | AI-Rad Companion Organs RTQKB · Traditional | 03/27/2025SE |
| K241770 | Prostate MR AI (VA10A)QDQ · Traditional | 03/05/2025SE |
| K240796 | myAblation Guide (VB80A)QTZ · Traditional | 08/06/2024SE |
Questions and answers
When was AI-Rad Companion Prostate MR cleared by the FDA?
AI-Rad Companion Prostate MR (K252608) received a 510(k) decision of Substantially Equivalent on September 9, 2025, 22 days after the submission was received.
What is the product code of K252608?
The FDA product code is LLZ – System, Image Processing, Radiological, a Class II (moderate risk) device regulated under 21 CFR 892.2050.