MI View&GO
FDA 510(k) K254016 · Siemens Medical Solutions USA, Inc.
510(k) numberK254016
Submission
- Device name
- MI View&GO
- Applicant
- Siemens Medical Solutions USA, Inc.
Hoffman Estates, IL, US - Received
- December 15, 2025
- Decision date
- February 10, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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.
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| K261641 | Lower Limb AI (LLAI)QIH · Traditional | AI Planning Logic, Inc. | 08/18/2026SE |
| K253794 | Prostate CoreQIH · Traditional | Lucida Medical, Ltd. | 08/10/2026SE |
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| K261315 | Symbia Pro.specta Q3 (11364751);Symbia Pro.specta X3 (11364752);Symbia Pro.specta X7…KPS · Special | 05/21/2026SE |
| K254184 | syngo Application SoftwareQIH · Traditional | 04/29/2026SE |
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Questions and answers
When was MI View&GO cleared by the FDA?
MI View&GO (K254016) received a 510(k) decision of Substantially Equivalent on February 10, 2026, 57 days after the submission was received.
What is the product code of K254016?
The FDA product code is QIH – Automated Radiological Image Processing Software, a Class II (moderate risk) device regulated under 21 CFR 892.2050.