510(k) · Cleared
ClearedSynthVISION 1.0.0
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Synthesis Health Intelligence, Inc. · LLZ System, Image Processing, Radiological
Cleared on Aug 8, 2024 as substantially equivalent to K172490 (Client Outlook, Inc., 2018) after a 143-day review. Its family tree reaches back 2 generations to 2016.
- Decided
- Aug 8, 2024
- Review
- 143 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K161515 (2016). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
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 LLZ? 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 LLZ device
- #1 K230955 syngo Application Softwarescore 21.5 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K172490 | eUnitySummary page 4…sing system Classification Name: System, Image Processing, Radiological Regulation Number: 892.2050 Product Code(s): LLZ Legally Marketed Predicate Devices Predicate #: K172490 Predicate Trade Name (Primary Predicate is listed first): eUnity Product Code: LLZ Device Description Summary SynthVISION is… | 2018 |
What descends from it?
No later submission names this one as a predicate yet.
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 8 years and passes through 2 companies; a new generation was cleared every 6.5 years on median.
- None of the 2 ancestors has a recall.
- 3 other devices also cite its predicate K172490.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · LLZ
58in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LLZ
173in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LLZ
11in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LLZ
116in 2025
MAUDE reports naming product code LLZ, 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 | 76 | 36 | 20 | 152 |
| 2008 | 94 | 52 | 32 | 154 |
| 2009 | 70 | 62 | 21 | 145 |
| 2010 | 51 | 98 | 17 | 145 |
| 2011 | 106 | 79 | 30 | 454 |
| 2012 | 82 | 87 | 12 | 266 |
| 2013 | 95 | 84 | 64 | 1,130 |
| 2014 | 78 | 89 | 6 | 15,631 |
| 2015 | 64 | 90 | 16 | 211 |
| 2016 | 82 | 90 | 12 | 290 |
| 2017 | 78 | 107 | 5 | 104 |
| 2018 | 104 | 105 | 7 | 72 |
| 2019 | 74 | 107 | 2 | 88 |
| 2020 | 81 | 115 | 6 | 82 |
| 2021 | 83 | 116 | 3 | 70 |
| 2022 | 65 | 137 | 4 | 28 |
| 2023 | 87 | 157 | 8 | 26 |
| 2024 | 62 | 131 | 6 | 42 |
| 2025 | 58 | 173 | 11 | 116 |
| 2026 | 45 | 110 | 14 | — |
What is it indicated for?
SynthVISION is a software application that can be used within a web -browser to process and view DICOM and non-DICOM image data and associated medical information to aid in the day-to-day diagnostic activities of medical imaging professionals and those involved in the care of a patient. SynthVISION displays both lossy-compressed and lossless images. Lossy compressed images are always clearly labeled with the type and degree of data compression. The user…
Read the full statement (253 words)
SynthVISION is a software application that can be used within a web -browser to process and view DICOM and non-DICOM image data and associated medical information to aid in the day-to-day diagnostic activities of medical imaging professionals and those involved in the care of a patient.
SynthVISION displays both lossy-compressed and lossless images. Lossy compressed images are always clearly labeled with the type and degree of data compression. The user must determine if the degree of lossy compression is acceptable for their purposes. Prior to making any medical decisions, the user must view the images within the user’s scope of practice.
SynthVISION allows for 2D, multi-planar reformatted and 3D image display and manipulation of medical images, including rotation, measurement, annotation, zoom, window width/level and a variety of other standard tools that a user might need to aid in their diagnostic work.
Any display devices must adhere to applicable regulatory standards. Mobile use for mammography is only for reference and referrals.
SynthVISION utilizes modern authorization and authentication mechanisms that enforce secure access for permissioned users who view the imaging data. The system extends beyond the hospital/clinic/health care provider and its internal network. With proper authorization, SynthVISION can be accessed by users outside of the provider's internal network.
SynthVISION does not contact the patient.
Limitations:
Worklists, reporting information, image storage, image transmission, users, roles, and permissions are provided via connectivity to other information systems such as EMRs, Radiology Information Systems, Cardiology Information Systems, and Lab Information Systems and are not a part of the viewer.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K240724 · printed Nov 5, 2026
Cite this page
510(k) Report. “K240724: SynthVISION 1.0.0.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K240724
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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