MI View&GO— 510(k) K254016
Substantially EquivalentSiemens Medical Solutions USA, Inc.
FDA 510(k) clearance K254016 for MI View&GO, Substantially Equivalent on 2026-02-10. Applicant: Siemens Medical Solutions USA, Inc.. Device class: 2.
Summary
Siemens Medical Solutions USA's MI View&GO is filed under product code QIH, automated radiological image processing software. The record doesn't describe the software beyond its name and that code name.
Class II, 21 CFR 892.2050. Radiology is both the classification panel and the review panel, and it came in as a Special 510(k).
Siemens Medical Solutions USA filed from Hoffman Estates, Illinois. The substantially equivalent decision came 57 calendar days after receipt (December 15, 2025 to February 10, 2026).
Clearance details
- Applicant
- Siemens Medical Solutions USA, Inc.
- Product code
- Product code QIH
- Device class
- Class 2
- Regulation
- 21 CFR 892.2050
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Hoffman Estates, IL, US
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