MI View&GO
K254016Siemens Medical Solutions USA, Inc. · cleared 2026-02-10 · 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.8)
“The lung lobe segmentation algorithm was re-trained with additional data and is utilized within Auto Lung 3D.”
Validation studies (3)
Retrospective clinical
n=20 patients
endpoints: Dice coefficient (DSC); average symmetric surface distance (ASSD)
standards: PS 3.1 - 3.20 2023e, 62304 Edition 1.1 2015-06, 14971 Third Edition 2019-12, 62366-1 Edition 1.1 2020-06, 15223-1 Fourth edition 2021-07, 20417 First edition 2021-04
Retrospective clinical
n=20 patients
endpoints: average Dice coefficient; average symmetric surface distance (ASSD)
standards: PS 3.1 - 3.20 2023e, 62304 Edition 1.1 2015-06, 14971 Third Edition 2019-12, 62366-1 Edition 1.1 2020-06, 15223-1 Fourth edition 2021-07, 20417 First edition 2021-04
Retrospective clinical
n=129 patients
endpoints: number of intersections of PERCIST VOIs with suspicious uptake masks
standards: PS 3.1 - 3.20 2023e, 62304 Edition 1.1 2015-06, 14971 Third Edition 2019-12, 62366-1 Edition 1.1 2020-06, 15223-1 Fourth edition 2021-07, 20417 First edition 2021-04
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
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).