# K252634: Imagine® Enterprise Suite

- Pathway: 510(k) (Traditional)
- Applicant: Softlink International Private Limited
- Decided: Jan 16, 2026 after 149 days
- Product code: QIH (Automated Radiological Image Processing Software)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 16 generations back to K913770 (1991). 202 ancestors in all.
No later device cites it as a predicate yet.
3 of 203 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K222036: MPXA-2000, Medipixel, Inc. (2023) Summary page 6.
- K230196: syngo.via View&GO VA40A, Siemens Healthcare GmbH (2023) Summary page 6.

## Indications for use
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.

Source page: https://510kreport.com/device/K252634
Methodology: https://510kreport.com/methodology