AI-Rad Companion Brain MR
FDA 510(k) K253057 · Siemens Healthcare GmbH
510(k) numberK253057
Submission
- Device name
- AI-Rad Companion Brain MR
- Applicant
- Siemens Healthcare GmbH
Erlangen, DE - Received
- September 22, 2025
- Decision date
- January 22, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- QIH – Automated Radiological Image Processing Software
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 892.2050
- Specialty
- Radiology
To provide automated radiological image processing and analysis tools. Software implementing artificial intelligence including nonadaptive machine learning algorithms trained with clinical and/or artificial data. In these devices, the algorithm training data typically impacts device performance. Adaptive AI algorithms are not within scope of this product code.
Other 510(k)s with product code QIH
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261795 | Quicktome Software SuiteQIH · Traditional | Omniscient Neurotechnology Pty, Ltd. | 09/10/2026SE |
| K260879 | 4DMQIH · Traditional | Invia, LLC | 09/10/2026SE |
| K251417 | ReVISION 2QIH · Traditional | Argus Cognitive, Inc. | 09/09/2026SE |
| K260525 | NextMR SpineQIH · Traditional | MRI2CT, Inc. | 09/04/2026SE |
| K260811 | Heartvue.ProtonQIH · Traditional | Heartvue.ai, Inc. | 08/26/2026SE |
| K261595 | Ceevra Reveal 4QIH · Traditional | Ceevra, Inc. | 08/25/2026SE |
| K262127 | DS Core CBCT AnatomyQIH · Traditional | Dentsply Sirona | 08/21/2026SE |
| K260584 | BoneMRIQIH · Traditional | Mriguidance B.V. | 08/21/2026SE |
| K261641 | Lower Limb AI (LLAI)QIH · Traditional | AI Planning Logic, Inc. | 08/18/2026SE |
| K253794 | Prostate CoreQIH · Traditional | Lucida Medical, Ltd. | 08/10/2026SE |
More from Lucida Medical, Ltd.
| 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 |
| K252838 | MAGNETOM Sola; MAGNETOM Altea; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile; MAGNETOM Vida…LNH · Traditional | 12/19/2025SE |
| K252608 | AI-Rad Companion Prostate MRLLZ · Traditional | 09/09/2025SE |
| 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 Brain MR cleared by the FDA?
AI-Rad Companion Brain MR (K253057) received a 510(k) decision of Substantially Equivalent on January 22, 2026, 122 days after the submission was received.
What is the product code of K253057?
The FDA product code is QIH – Automated Radiological Image Processing Software, a Class II (moderate risk) device regulated under 21 CFR 892.2050.