510(k) · Cleared
ClearedImagine® Enterprise Suite
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Softlink International Private Limited · QIH Automated Radiological Image Processing Software
Cleared on Jan 16, 2026 as substantially equivalent to K222036 (Medipixel, Inc., 2023) and 1 other predicate after a 149-day review. Its family tree reaches back 16 generations to 1991. 3 of the 203 devices in its family, counting itself, have a Class I recall.
- Decided
- Jan 16, 2026
- Review
- 149 days
- Class
- Class II
- Product code
- QIH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 16 generations to K913770 (1991). 202 ancestors in all, the oldest K837107 (1983). No later device cites it as a predicate yet. 3 of the 203 devices in this family, counting this one, have a Class I recall.
- Root · 16 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 12 generations between
- 3 generations backK201477 syngo.via View&GOSiemens Healthcare GmbH · 2020
- 2 generations backK221501 syngo.via View&GOSiemens Healthcare GmbH · 2022
- 1 generation backK230196 syngo.via View&GO VA40ASiemens Healthcare GmbH · 2023
- This deviceK252634 Imagine® Enterprise SuiteSoftlink International Private Limited · 2026
Show all 16 generations
- Root · 16 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 15 generations backK963345 Advantage Windows Tissue Volume OptionGE Medical Systems · 1996
- 14 generations backK013381 Advanced Lung Analysis-1General Electric Co. · 2001
- 13 generations backK022013 Lungcare CT Software PackageSiemens Medical Solutions USA, Inc. · 2002
- 12 generations backK033374 Lungcare CT Software Package with Extended FunctionalitySiemens AG Medical Solutions · 2003
- 11 generations backK041484 UndecidedSiemens Medical Solutions USA, Inc. · 2004
- 10 generations backK053301 Cedara I-Response Cedara Pet/CTCedara Software Corp. · 2006
- 9 generations backK071950 Syngo TruedSiemens Medical Solutions USA, Inc. · 2007
- 8 generations backK091373 Syngo TruedSiemens Medical Solutions USA, Inc. · 2009
- 7 generations backK101749 Syngo Trued SoftwareSiemens Medical Solutions · 2010
- 6 generations backK123920 Syngo.ViaSiemens AG Medical Solutions · 2013
- 5 generations backK150843 syngo®.via (version VB10A)Siemens AG · 2015
- 4 generations backK182208 syngo.via View&GO (Version VA10A)Siemens Healthcare GmbH · 2018
- 3 generations backK201477 syngo.via View&GOSiemens Healthcare GmbH · 2020
- 2 generations backK221501 syngo.via View&GOSiemens Healthcare GmbH · 2022
- 1 generation backK230196 syngo.via View&GO VA40ASiemens Healthcare GmbH · 2023
- This deviceK252634 Imagine® Enterprise SuiteSoftlink International Private Limited · 2026
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −16 | K913770 | Advantage V.S. CT/MR Rad Diagnostic Workstation | General Electric Co. | 1991 | — |
| −15 | K963345 | Advantage Windows Tissue Volume Option | GE Medical Systems | 1996 | — |
| −14 | K013381 | Advanced Lung Analysis-1 | General Electric Co. | 2001 | — |
| −13 | K022013 | Lungcare CT Software Package | Siemens Medical Solutions USA, Inc. | 2002 | — |
| −12 | K033374 | Lungcare CT Software Package with Extended Functionality | Siemens AG Medical Solutions | 2003 | — |
| −11 | K041484 | Undecided | Siemens Medical Solutions USA, Inc. | 2004 | — |
| −10 | K053301 | Cedara I-Response Cedara Pet/CT | Cedara Software Corp. | 2006 | — |
| −9 | K071950 | Syngo Trued | Siemens Medical Solutions USA, Inc. | 2007 | — |
| −8 | K091373 | Syngo Trued | Siemens Medical Solutions USA, Inc. | 2009 | — |
| −7 | K101749 | Syngo Trued Software | Siemens Medical Solutions | 2010 | — |
| −6 | K123920 | Syngo.Via | Siemens AG Medical Solutions | 2013 | — |
| −5 | K150843 | syngo®.via (version VB10A) | Siemens AG | 2015 | — |
| −4 | K182208 | syngo.via View&GO (Version VA10A) | Siemens Healthcare GmbH | 2018 | — |
| −3 | K201477 | syngo.via View&GO | Siemens Healthcare GmbH | 2020 | — |
| −2 | K221501 | syngo.via View&GO | Siemens Healthcare GmbH | 2022 | — |
| −1 | K230196 | syngo.via View&GO VA40A | Siemens Healthcare GmbH | 2023 | — |
| 0 (this device) | K252634 | Imagine® Enterprise Suite | Softlink International Private Limited | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 1987 | 1 | 0 |
| 1988 | 2 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 5 | 0 |
| 1992 | 4 | 0 |
| 1993 | 2 | 0 |
| 1994 | 6 | 0 |
| 1995 | 7 | 0 |
| 1996 | 8 | 0 |
| 1997 | 9 | 0 |
| 1998 | 14 | 0 |
| 1999 | 9 | 0 |
| 2000 | 11 | 0 |
| 2001 | 18 | 0 |
| 2002 | 13 | 0 |
| 2003 | 9 | 0 |
| 2004 | 16 | 0 |
| 2005 | 12 | 0 |
| 2006 | 10 | 0 |
| 2007 | 8 | 1 |
| 2008 | 4 | 0 |
| 2009 | 4 | 0 |
| 2010 | 2 | 1 |
| 2011 | 4 | 0 |
| 2012 | 4 | 1 |
| 2023 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
3 devices in this family have a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new QIH device
- #1 K213998 cvi42 Auto Imaging Software Applicationscore 23.5 · 7 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K222036 | MPXA-2000Summary page 6…510(k) SUMMARY III. PREDICATE DEVICES Primary Predicate Device Predicate Device Name : MPXA-2000 510(k) Number : K222036 Device Classification Name : Automated Radiological Image Processing Software Class… | 2023 |
| * | K230196 | syngo.via View&GO VA40ASummary page 6…: QIH Reference Predicate Device Predicate Device Name : Syngo.via View&GO (Version VA40A) 510(k) Number : K230196 Device Classification Name : System, image processing, radiological Class : Clas… | 2023 |
| † | K232147 | CAAS Workstation | 2024 |
| † | K182611 | Qangio XA 3D | 2019 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (3 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K121434Software Syngo MR D13A for the Magnetom Systems Aera/Skyra/Avanto/VerioSiemens Medi Cal Solutions, Inc. · 2012 · 7 generations back · ◆ in the 2012 ancestors bar of FIG. 12 Class I recalls
- K101347Magnetom Aera; Magnetom SkyraSiemens Medical Solutions USA, Inc. · 2010 · 9 generations back · ◆ in the 2010 ancestors bar of FIG. 12 Class I recalls
- K072237Magnetom VerioSiemens Medical Solutions USA, Inc. · 2007 · 9 generations back · ◆ in the 2007 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 35 years and passes through 9 companies; a new generation was cleared every 1.8 years on median.
- 44 of the 202 ancestors have a recall of any class; 3 have a Class I recall.
How does its category compare?
All QIH devicesQIH Automated Radiological Image Processing Software: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · QIH
94in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QIH
150in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · QIH
1so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · QIH
4in 2025
MAUDE reports naming product code QIH, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 2 | — | 0 | 0 |
| 2020 | 11 | 145 | 0 | 0 |
| 2021 | 19 | 125 | 0 | 0 |
| 2022 | 25 | 134 | 0 | 0 |
| 2023 | 45 | 151 | 0 | 0 |
| 2024 | 64 | 141 | 0 | 2 |
| 2025 | 94 | 150 | 0 | 4 |
| 2026 | 78 | 130 | 1 | — |
What is it indicated for?
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…
Read the full statement (157 words)
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K252634 · printed Nov 5, 2026
Cite this page
510(k) Report. “K252634: Imagine® Enterprise Suite.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K252634
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026