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.”
AlgorithmFDA source did not state this
Adaptive (vs locked)FDA source did not state this
PCCPNo
Cybersecurity addressedNo

Validation studies (1)

Bench

sample size not stated

endpoints: all software specifications have met the predetermined acceptance criteria; all requirement and functional specifications, including specifications related to device hazards

standards: PS 3.1-3.20 2023e Digital Imaging and Communications in Medicine (DICOM) Set, 62304 Edition 1.1 2015-06 CONSOLIDATED VERSION Medical Device Software -Software Life Cycle Processes, 14971 Third Edition 2019-12 Medical devices - Application of risk management to medical devices, 62366-1 Edition 1.1 2020-06 CONSOLIDATED VERSION Medical devices - Part 1: Application of usability engineering to medical devices, 15223-1 Fourth edition 2021-07 Medical devices - Symbols to be used with medical device labels, labelling, and information to be supplied - Part 1: General requirements, 20417 First edition 2021-04 Corrected version 2021-12 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

0
recalls in product code, 24mo
3
MAUDE reports in code, 12mo
—
vs code's own 3-yr baseline
1
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); a recall is shown as device-attributed only when the recall record itself lists this clearance number. 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).

Applicable FDA guidance — what the submission is measured against

FDA guidance documents and guiding principles applicable to 510(k) AI/ML devices in the Radiology panel. A curated reference index, not legal or regulatory advice — each item states its own status, and a draft is never binding.

Applicability is derived from the device's FDA advisory panel and pathway — cross-cutting guidances apply to every AI/ML device; panel-specific ones are flagged. Titles, dates, and links verified against fda.gov as of July 2026.

Constat Precedent · public FDA/CMS data · descriptive decision-support, not regulatory or reimbursement advice. Share this page: constat.dev/precedent/device/K242300