syngo.via MI WorkFlows, Scenium, syngo MBF
A print-ready facts sheet for procurement and governance files — public records, sources included.
Siemens Medical Solutions USA, Inc. · cleared 2021-06-10 under product code QIH (Automated Radiological Image Processing Software).
The public record
| 510(k) number | K211459 (FDA database) |
| Device name as cleared | syngo.via MI WorkFlows, Scenium, syngo MBF |
| Applicant | Siemens Medical Solutions USA, Inc. (Knoxville, TN, US) |
| Decision | Substantially Equivalent · Special pathway |
| Decision date | 2021-06-10 |
| FDA product code | QIH — Automated Radiological Image Processing Software |
| Review panel | Radiology |
Source: openFDA 510(k) records, stored verbatim. Entry added 2026-08-29; the source link above is authoritative if any discrepancy exists.
Public disclosure beyond the clearance
| FDA clearance record | Located — linked above |
| Public model card / intended-use document | Not yet located in public sources |
| Peer-reviewed validation publication | Not yet located in public sources |
| Published subgroup / equity performance | Not yet located in public sources |
| Public monitoring or update commitments | Not yet located in public sources |
"Not yet located" is a statement about what we could find in public sources — not a statement about the product or whether such materials exist privately. Vendors: these rows update free of charge on submission of a public link — start here.
Literature mentioning this clearance number
The last search of Europe PMC for this clearance number, on 2026-09-12, did not complete. No conclusion should be drawn from this section until it does; it is a failed lookup, not a result.
Method: an automated full-text search of
Europe PMC for the exact string
K211459. A result means the publication's indexed text contains this
clearance number — nothing more. It is not a finding that the publication
validates this device, and the number of results is not a score. A clearance number appears
in the literature as a predicate citation or a comparator at least as often as it appears as
the subject of a study. Re-run this search yourself.
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This entry states public facts only and is not an evaluation or recommendation of this product. Full verification path: registry record, checklist, contract terms.