MI View&GO

K222172

Siemens Medical Solutions USA, Inc. · cleared 2022-08-19 · product code QIH · Radiology

Premarket evidence — what FDA accepted

Device typesamd
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.”
AlgorithmAn 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.
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.”
Adaptive (vs locked)FDA source did not state this
PCCPNo
Cybersecurity addressedYes
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

0
recalls in product code, 24mo
3
MAUDE reports in code, 12mo
—
vs code's own 3-yr baseline
2
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

  • 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); 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/K222172