MI View&GO
K222172Siemens Medical Solutions USA, Inc. · cleared 2022-08-19 · product code QIH · Radiology
Premarket evidence — what FDA accepted
source quote (p.6)
“MI View&GO is a software-only medical device which will be delivered in conjunction with Siemens SPECT/CT and PET/CT scanners.”
source quote (p.7)
“An individual software program, or group of programs, routines, or algorithms that add specific image processing and/or analysis capabilities to a positron emission tomography (PET) and Single Photon Emission Computed Tomography (SPECT) imaging system configuration. A basic set of application programs and routines is included with such computer controlled imaging systems and they can be upgraded to correct programming errors or to add new system capabilities. Some application software routines or groups of routines (packages) must be combined with specific hardware or firmware accessories or configurations in order to function as intended. Application program packages are typically identified by a proprietary name and “version” or “upgrade” number. The modification to the MI View&GO software that is the subject of this 510(k) Premarket Notification is the addition of the following features: Auto Lung 3D, Gaussian Filter, FAST Ranges Enhancements, Automatic Layout Enhancements, Open Apps, Shared Software Component Tools and CT Plugins (Tools Export Tool, TimeCurve, Segmentation Tools, Synchronization Group Configuration, Oncology Extension Plugin, Interactive Spectral Imaging Plugin, Sim&GO Plugin), Layout and User Interface Improvements, Minor Usability Improvements.”
source quote (p.8)
“Cybersecurity information in accordance with FDA Guidance documents issued October 2, 2014, has been provided. The software has specific cybersecurity controls to prevent unauthorized access, modifications, misuse, or denial of use. Additionally, controls are enabled to prevent the unauthorized use of information that is stored, accessed, or transferred between the software and external devices.”
Validation studies (1)
Bench
sample size not stated
standards: IEC 62304, NEMA Standard PS 3.1-3.20, ISO 14971, AAMI / ANSI / IEC 62366-1, ISO 15223-1
Reported performance (0 observations)
FDA source did not state a quantitative performance metric — non-reporting is itself the signal.
Each value carries its own analysis unit and task — never compare or pool across devices. Source: 510(k) summary PDF.
Predicate network
Postmarket — what happened after clearance
- re_clearance
The FDA AI/ML device list shows a newer 510(k) K254016 (decision 2026-02-10) from Siemens Medical Solutions USA, Inc. for a matching device line ("MI View&GO") — a new clearance for the same line is a change event.
first seen 2026-07-08 · k_number:K254016
- re_clearance
The FDA AI/ML device list shows a newer 510(k) K242300 (decision 2024-08-30) from Siemens Medical Solutions USA, Inc. for a matching device line ("MI View&GO") — a new clearance for the same line is a change event.
first seen 2026-07-08 · k_number:K242300
Recall and MAUDE counts are product-code-level (reports aren't reliably attributable to one device). Signals are descriptive observables with sources — never a judgment that the device is unsafe or drifting. Snapshot 2026-07-08.
Reimbursement — how devices like this got paid
Not yet tracked — no payment pathway indexed for this clearance (the reimbursement corpus is a growing seed set).