LVivo IQS
A print-ready facts sheet for procurement and governance files — public records, sources included.
Dia Imaging Analysis, Ltd. · cleared 2023-02-01 under product code QIH (Automated Radiological Image Processing Software).
The public record
| 510(k) number | K222970 (FDA database) |
| Device name as cleared | LVivo IQS |
| Applicant | Dia Imaging Analysis, Ltd. (Beer-Sheva, IL) |
| Decision | Substantially Equivalent · Traditional pathway |
| Decision date | 2023-02-01 |
| 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
Searched 2026-09-27 — no indexed publication mentioning
K222970 was found in Europe PMC.
This is a statement about a full-text search on a date, not about the device and not about whether validation work exists. Clearance numbers are frequently absent from papers that do concern the device, and publications appear in the index months after they appear in a journal. Vendors: a publication link sent to the Institute is added free of charge.
Method: an automated full-text search of
Europe PMC for the exact string
K222970. 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.