Imagine® Enterprise Suite

K252634

Softlink International Private Limited · cleared 2026-01-16 · product code QIH · Radiology

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.4)
“Imagine® Enterprise Suite (IES) is a medical diagnostic device that receives, stores, and shares the medical images from and to DICOM-compliant entities such as imaging modalities (such as X-ray Angiograms (XA), Echocardiograms (US), MRI, CT, CR, DR, IVUS, OCT, PET and SPECT), external PACS, and other diagnostic workstations. It is used in the display and quantification of medical images, after image acquisition from modalities, for post-procedure clinical decision support. It constitutes a PACS for the communication and storage of medical images and provides a worklist of stored medical images that can be used to open patient studies in one of its image viewers. It is intended to display images and related information that are interpreted by trained professionals to render findings and/or diagnosis, but it does not directly generate any diagnosis or potential findings. Not intended for primary diagnosis of mammographic images. Not intended for intra-procedural or real-time use. Not intended for diagnostic use on mobile devices.”
Algorithmdeep learning methodology for image analysis for segmentation of coronary vessels
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.”
Adaptive (vs locked)No
source quote (p.17)
“The best-performing model was selected for further training and validation and subsequently evaluated using a comprehensive set of performance metrics, including Jaccard Index (Intersection over Union), Dice Score, Precision, Accuracy, and Recall, in conjunction with visual assessment.”
PCCPNo
Cybersecurity addressedYes
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)

Retrospective clinical

n=762 cases

endpoints: Jaccard Index (Intersection over Union); Dice Score; Precision; Accuracy; Recall

standards: FDA Guidance, Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, 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 (5 observations)

iouas written: “Jaccard Index (Intersection over Union)”stated without value
source quote (p.17)
“subsequently evaluated using a comprehensive set of performance metrics, including Jaccard Index (Intersection over Union), Dice Score, Precision, Accuracy, and Recall, in conjunction with visual assessment.”
diceas written: “Dice Score”stated without value
source quote (p.17)
“subsequently evaluated using a comprehensive set of performance metrics, including Jaccard Index (Intersection over Union), Dice Score, Precision, Accuracy, and Recall, in conjunction with visual assessment.”
ppvas written: “Precision”stated without value
source quote (p.17)
“subsequently evaluated using a comprehensive set of performance metrics, including Jaccard Index (Intersection over Union), Dice Score, Precision, Accuracy, and Recall, in conjunction with visual assessment.”
accuracyas written: “Accuracy”stated without value
source quote (p.17)
“subsequently evaluated using a comprehensive set of performance metrics, including Jaccard Index (Intersection over Union), Dice Score, Precision, Accuracy, and Recall, in conjunction with visual assessment.”
sensitivityas written: “Recall”stated without value
source quote (p.17)
“subsequently evaluated using a comprehensive set of performance metrics, including Jaccard Index (Intersection over Union), Dice Score, Precision, Accuracy, and Recall, in conjunction with visual assessment.”

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

0
recalls in product code, 24mo
3
MAUDE reports in code, 12mo
—
vs code's own 3-yr baseline
0
drift signals on this device

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 2026-07-08.

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).

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.

Constat Precedent · public FDA/CMS data · descriptive decision-support, not regulatory or reimbursement advice. Share this page: constat.dev/precedent/device/K252634