MI View&GO

K242300

Siemens Medical Solutions USA, Inc. · cleared 2024-08-30 · product code QIH · Radiology

Premarket evidence — what FDA accepted

Device typesamd

source quote (p.5)

“MI View&GO is a software-only medical device which will be delivered in conjunction with Siemens SPECT/CT and PET/CT scanners.”

AlgorithmThe MI View&GO software integrates molecular imaging more efficiently in the clinical environment by providing an interface for its users to review, post-process and read medical images immediately after acquisition. The purpose of the MI View&GO is to allow the technologist and reading physician to: Review acquired and reconstructed images at the scanner console Determine that the acquired data is of sufficient quality for reading, so the patient can be released. Prepare images for reading Perform a basic read. MI Features include Brain AC-PC(Anterior Commissure – Posterior Commissure), PERCIST, VOI Isocontour. Shared Software Common Tools and CT Features include Layout Editor, Average, Stroke Layout. Layout Improvements include MIP (Maximum Intensity Projection) Rotation, Volume Stripe Image Order.

source quote (p.5)

“The MI View&GO software integrates molecular imaging more efficiently in the clinical environment by providing an interface for its users to review, post-process and read medical images immediately after acquisition. The purpose of the MI View&GO is to allow the technologist and reading physician to: Review acquired and reconstructed images at the scanner console Determine that the acquired data is of sufficient quality for reading, so the patient can be released. Prepare images for reading Perform a basic read MI Features: Brain AC-PC(Anterior Commissure – Posterior Commissure) PERCIST VOI Isocontour Shared Software Common Tools and CT Features: Layout Editor Average Stroke Layout Layout Improvements: MIP (Maximum Intensity Projection) Rotation Volume Stripe Image Order”

Adaptive (vs locked)FDA source did not state this

PCCPNo

Cybersecurity addressedNo

Validation studies (1)

Bench

sample size not stated

standards: Digital Imaging and Communications in Medicine (DICOM) Set, Medical Device Software -Software Life Cycle Processes, Medical devices - Application of risk management to medical devices, Medical devices - Part 1: Application of usability engineering to medical devices, Medical devices - Symbols to be used with medical device labels, labelling, and information to be supplied - Part 1: General requirements, Medical devices - Information to be supplied by the manufacturer

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

recalls in product code, 24mo

MAUDE reports in code, 12mo

—

vs code's own 3-yr baseline

drift signals on this device

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

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).