Imagine® Enterprise Suite
K252634Softlink International Private Limited · cleared 2026-01-16 · product code QIH · Radiology
Premarket evidence — what FDA accepted
source quote (p.7)
“The Imagine® Enterprise Suite (IES) is integrated with ML only for the segmentation of coronary vessels from X-ray angiographic images and uses deep learning methodology for image analysis.”
source quote (p.7)
“The Imagine® Enterprise Suite (IES) is integrated with ML only for the segmentation of coronary vessels from X-ray angiographic images and uses deep learning methodology for image analysis.”
source quote (p.18)
“The Imagine® Enterprise Suite complies with the cybersecurity requirements by implementing a process that prevents unauthorized access, modifications, misuse, denial of use, or unauthorized use of information stored, accessed, or transferred from a medical device to an external recipient.”
Validation studies (1)
Standalone
n=30 patients
endpoints: Jaccard Index (Intersection over Union); Dice Score; Precision; Accuracy; Recall; visual assessment
standards: IEC 62304:2006 + A1:2015, ANSI AAMI ISO 14971:2019, IEC 62366-1:2020, IEC 82304-1:2016, NEMA PS 3.1–3.20:2023e
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).