ViewFinder Software Version 1.1

K223501

Elaitra Ltd · cleared 2023-04-21 · product code QIH · Radiology

FDA 510(k) summary for ViewFinder Software Version 1.1 (K223501)

Constat organizes this clearance into predicate context, validation evidence, reported performance, postmarket signals, and reimbursement links. Each extracted claim stays tied to the public FDA source; missing fields remain explicitly unstated.

Validation studies
1
Cited predicates
1
Performance observations
1
Product code
QIH
Official FDA 510(k) database record ↗FDA 510(k) source PDF ↗

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.5)
“ViewFinder is software which displays two Digital Breast Tomosynthesis (DBT) views of the same breast and dynamically indicates correlated (matched) tissue.”
Algorithmproprietary Artificial Intelligence and Machine Learning algorithms
source quote (p.9)
“ViewFinder uses proprietary Artificial Intelligence and Machine Learning algorithms.”
Adaptive (vs locked)No
source quote (p.9)
“The algorithms are 'locked' so that their output only changes in the laboratory under controlled conditions and do not change in the field.”
PCCPFDA source did not state this
Cybersecurity addressedYes
source quote (p.13)
“Content of Premarket Submission for Management of Cybersecurity in Medical Devices - Guidance for Industry and Food and Drug Administration Staff Document Issued on October 2, 2014”

Validation studies (1)

Bench

n=28 patients · 1 site(s)

endpoints: correct mapping percentage; Total Registration Errors (TRE)

standards: ISO 14971: 2019, IEC 62304:2006/A1:2016, NEMA PS 3.1 - 3.20 2016, IEC 82304-1: 2016

Reported performance (1 observation)

sensitivity0.853CI 58/68
source quote (p.10)
“Total 1.000 (4/4) 0.786 (33/42) 0.950 (19/20) 1.000 (2/2) 0.853 (58/68)”

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

1
recalls in product code, 24mo
4
MAUDE reports in code, 12mo
—
vs code's own 3-yr baseline
1
drift signals on this device
  • recall_reason_pattern

    Software/algorithm-related recall in product code QIH (PIE Medical Imaging B.V., initiated 2026-05-07): "User measurement value reported by diagnostic bioimaging software intended to measure/visualize cardiovascular structures may be larger (0.8% to 34.4%) than the actual anatomical d" Recalling firm is another firm in the same product code.

    first seen 2026-08-26 · recall res_event_number:98930

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 2026-08-26.

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.

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Constat Precedent · public FDA/CMS data · descriptive decision-support, not regulatory or reimbursement advice. Share this page: constat.dev/precedent/device/K223501