ViewFinder Software Version 1.1
K223501Elaitra Ltd · cleared 2023-04-21 · product code QIH · Radiology
Premarket evidence — what FDA accepted
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. ViewFinder is a standalone software application or can be integrated into medical image management and processing systems.”
source quote (p.8)
“DBT Registration Algorithms Finite Element Model and Deep Learning”
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. This follows the FDA's current classification framework for Al and ML algorithms. The algorithm's predictions only change when a new version of the software is released.”
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)
Retrospective clinical
n=28 patients · 1 site(s)
endpoints: correct mapping percentage (where the ground truth matching tissue is inside the target area); Total Registration Errors (TRE); Frequency that ground truth is inside oval
standards: ISO 14971: 2019, IEC 62304:2006/A1:2016, NEMA PS 3.1 - 3.20 2016, IEC 82304-1: 2016
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).