510(k) · Cleared
ClearedReady View
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ge Healthcare (Ge Medical Systems Scs) · LLZ System, Image Processing, Radiological
Cleared on Jun 15, 2012 as substantially equivalent to K110573 (Ge Healthcare (Ge Medical Systems Scs), 2011) after a 207-day review. Its family tree reaches back 4 generations to 1987. 2 later devices descend from it.
- Decided
- Jun 15, 2012
- Review
- 207 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K871859 (1987). 10 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK871859 CT9800 Quick 3D #B7919DAGeneral Electric Co. · 1987
- 3 generations backK972399 Advantage Windows Volume Rendering OptionGe Medical Systems, Inc. · 1997 · Recalled
- 2 generations backK041521 Volume Viewer PlusGeneral Electric Medical Systems · 2004 · Recalled
- 1 generation backK110573 Ready ViewGe Healthcare (Ge Medical Systems Scs) · 2011 · Recalled
- This deviceK113456 Ready ViewGe Healthcare (Ge Medical Systems Scs) · 2012
- Descendant · cites it directly · 0 of its ownK233714 BreViewGE Medical Systems SCS · 2024
- Descendant · cites it directly · 0 of its ownK141514 Synapse 3D Tensor AnalysisFujifilm Meidcal Systems U.S.A.,Inc. · 2014
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K871859 | CT9800 Quick 3D #B7919DA | General Electric Co. | 1987 | — |
| −3 | K972399 | Advantage Windows Volume Rendering Option | Ge Medical Systems, Inc. | 1997 | 1 |
| −2 | K041521 | Volume Viewer Plus | General Electric Medical Systems | 2004 | 2 |
| −1 | K110573 | Ready View | Ge Healthcare (Ge Medical Systems Scs) | 2011 | 1 |
| 0 (this device) | K113456 | Ready View | Ge Healthcare (Ge Medical Systems Scs) | 2012 | — |
| +1 | K233714 | BreView | GE Medical Systems SCS | 2024 | — |
| +1 | K141514 | Synapse 3D Tensor Analysis | Fujifilm Meidcal Systems U.S.A.,Inc. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 2 | 0 |
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2024 | 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 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 |
|---|---|---|---|
| * | K110573 | Ready ViewSummary page 1…iving and communication system Product Code: 90 LLZ Predicate Device: READY View 0<110573) Device Description: READY VIEW 1K110573) is a suite of applications developed to improve multi-porametric exams by enabling the analysis o… | 2011 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 25 years and passes through 4 companies; a new generation was cleared every 6.9 years on median.
- 5 of the 10 ancestors have a recall of any class.
- Of its descendants, K233714 (GE Medical Systems SCS, 2024) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K110573.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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?
READY View is an image analysis software that allows the user to process dynamic or
functional volumetric data and to generate maps that display changes in image intensity
over time, echo time, bo-value (Diffusion imaging) and frequency (Spectroscopy). The
combination of acquired images, reconstructed images, calculated parametric images, tissue
segmentation, annotations and measurement performed by the clinician allows multi-
parametric analysis and may provide clinically relevant information for diagnosis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K113456 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113456: Ready View.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113456
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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