510(k) · Cleared
ClearedSynapse PACS (7.5)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
FUJIFILM Healthcare Americas Corporation · QIH Automated Radiological Image Processing Software
Cleared on Jun 30, 2025 as substantially equivalent to K190232 (Fujifilm Corporation, 2019) and 1 other predicate after a 216-day review. Its family tree reaches back 13 generations to 1991. 1 later device descends from it.
- Decided
- Jun 30, 2025
- Review
- 216 days
- Class
- Class II
- Product code
- QIH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 13 generations to K913770 (1991). 137 ancestors in all, the oldest K871859 (1987). 1 later device descends from it, 1 citing it directly.
- Root · 13 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 9 generations between
- 3 generations backK113244 Synapse MPR FusionFujifilm Medical System U.S.A., Inc. · 2011
- 2 generations backK160108 Synapse PACSFujifilm Medical Systems U.S.A, Inc. · 2016 · Recalled
- 1 generation backK190232 Synapse PACSFujifilm Corporation · 2019 · Recalled
- This deviceK243647 Synapse PACS (7.5)FUJIFILM Healthcare Americas Corporation · 2025
- Descendant · cites it directly · 0 of its ownK261713 Synapse PACS (7.6.0)FUJIFILM Healthcare Americas Corporation · 2026
Show all 13 generations
- Root · 13 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 12 generations backK963345 Advantage Windows Tissue Volume OptionGE Medical Systems · 1996
- 11 generations backK013381 Advanced Lung Analysis-1General Electric Co. · 2001
- 10 generations backK022013 Lungcare CT Software PackageSiemens Medical Solutions USA, Inc. · 2002
- 9 generations backK033374 Lungcare CT Software Package with Extended FunctionalitySiemens AG Medical Solutions · 2003
- 8 generations backK041484 UndecidedSiemens Medical Solutions USA, Inc. · 2004
- 7 generations backK053301 Cedara I-Response Cedara Pet/CTCedara Software Corp. · 2006
- 6 generations backK071950 Syngo TruedSiemens Medical Solutions USA, Inc. · 2007
- 5 generations backK091373 Syngo TruedSiemens Medical Solutions USA, Inc. · 2009
- 4 generations backK101228 Mirada XDMirada Medical, Ltd. · 2010
- 3 generations backK113244 Synapse MPR FusionFujifilm Medical System U.S.A., Inc. · 2011
- 2 generations backK160108 Synapse PACSFujifilm Medical Systems U.S.A, Inc. · 2016 · Recalled
- 1 generation backK190232 Synapse PACSFujifilm Corporation · 2019 · Recalled
- This deviceK243647 Synapse PACS (7.5)FUJIFILM Healthcare Americas Corporation · 2025
Most influential descendants
Showing 1 of 1 · See all- K261713Synapse PACS (7.6.0)FUJIFILM Healthcare Americas Corporation · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K913770 | Advantage V.S. CT/MR Rad Diagnostic Workstation | General Electric Co. | 1991 | — |
| −12 | K963345 | Advantage Windows Tissue Volume Option | GE Medical Systems | 1996 | — |
| −11 | K013381 | Advanced Lung Analysis-1 | General Electric Co. | 2001 | — |
| −10 | K022013 | Lungcare CT Software Package | Siemens Medical Solutions USA, Inc. | 2002 | — |
| −9 | K033374 | Lungcare CT Software Package with Extended Functionality | Siemens AG Medical Solutions | 2003 | — |
| −8 | K041484 | Undecided | Siemens Medical Solutions USA, Inc. | 2004 | — |
| −7 | K053301 | Cedara I-Response Cedara Pet/CT | Cedara Software Corp. | 2006 | — |
| −6 | K071950 | Syngo Trued | Siemens Medical Solutions USA, Inc. | 2007 | — |
| −5 | K091373 | Syngo Trued | Siemens Medical Solutions USA, Inc. | 2009 | — |
| −4 | K101228 | Mirada XD | Mirada Medical, Ltd. | 2010 | — |
| −3 | K113244 | Synapse MPR Fusion | Fujifilm Medical System U.S.A., Inc. | 2011 | — |
| −2 | K160108 | Synapse PACS | Fujifilm Medical Systems U.S.A, Inc. | 2016 | 4 |
| −1 | K190232 | Synapse PACS | Fujifilm Corporation | 2019 | 11 |
| 0 (this device) | K243647 | Synapse PACS (7.5) | FUJIFILM Healthcare Americas Corporation | 2025 | — |
| +1 | K261713 | Synapse PACS (7.6.0) | FUJIFILM Healthcare Americas Corporation | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 5 | 0 |
| 1992 | 2 | 0 |
| 1993 | 2 | 0 |
| 1994 | 4 | 0 |
| 1995 | 5 | 0 |
| 1996 | 7 | 0 |
| 1997 | 7 | 0 |
| 1998 | 7 | 0 |
| 1999 | 3 | 0 |
| 2000 | 10 | 0 |
| 2001 | 15 | 0 |
| 2002 | 11 | 0 |
| 2003 | 10 | 0 |
| 2004 | 12 | 0 |
| 2005 | 5 | 0 |
| 2006 | 4 | 0 |
| 2007 | 4 | 0 |
| 2010 | 2 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2015 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 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.
Planning a device in QIH? 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 |
|---|---|---|---|
| * | K190232 | Synapse PACSSummary page 5…21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K190232 Synapse PACS LLZ K221677… | 2019 |
| * | K221677 | Synapse 3D Base Tools v6.6Summary page 5…irst) Product Code K190232 Synapse PACS LLZ K221677 Synapse 3D Base Tools v6.6 LLZ Device Descripti… | 2022 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K261713 | Synapse PACS (7.6.0) | 2026 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 34 years and passes through 10 companies; a new generation was cleared every 1.5 years on median.
- 32 of the 137 ancestors have a recall of any class.
- Of its descendants, K261713 (FUJIFILM Healthcare Americas Corporation, 2026) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K190232.
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. 2025, 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?
FUJIFILM Synapse PACS Software is intended for use as a web-based application on an off-the shelf PC which meets or exceeds minimum specifications and is networked with a FUJIFILM Synapse PACS server. The FUJIFILM Synapse PACS Software can process medical images from DICOM compliant modalities and non-DICOM sources. FUJIFILM Synapse PACS Software provides toolsets for: * Performing measurements on DICOM images * Regional segmentation * Importing and…
Read the full statement (206 words)
FUJIFILM Synapse PACS Software is intended for use as a web-based application on an off-the shelf PC which meets or exceeds minimum specifications and is networked with a FUJIFILM Synapse PACS server.
The FUJIFILM Synapse PACS Software can process medical images from DICOM compliant modalities and non-DICOM sources.
FUJIFILM Synapse PACS Software provides toolsets for:
* Performing measurements on DICOM images
* Regional segmentation
* Importing and presenting data from modalities (DICOM and non-DICOM),
* Solving clinical calculations
* Creating and distributing structured reports
FUJIFILM Synapse PACS Software is intended to serve as the primary user interface for the processing of medical images for presentation on displays appropriate to the medical task being performed. It enables the display, comparison, fusion, and volume rendering of studies to aid in reading, interpreting, reporting, and treatment planning.
Typical users are radiologists, cardiologists, technologists, sonographers, technicians, nurses, and clinicians.
MIP, MPR Fusion, and volume rendering are not intended for mammography use. FUJIFILM Synapse PACS Software can be used to process FUJIFILM's DICOM MG "For Processing" images and also for the display, manipulation, and interpretation of lossless compressed or non-compressed mammography images that have been received in the DICOM For Presentation format and displayed on FDA-cleared, DICOM compatible displays for mammography.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K243647 · printed Nov 6, 2026
Cite this page
510(k) Report. “K243647: Synapse PACS (7.5).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K243647
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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