510(k) · Cleared
Cleared3DI
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shina Systems, Ltd. · LLZ System, Image Processing, Radiological
Cleared on Feb 16, 2012 as substantially equivalent to K112530 (Shina Systems, Ltd., 2011) after an 87-day review. Its family tree reaches back 9 generations to 1993.
- Decided
- Feb 16, 2012
- Review
- 87 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K930090 (1993). 29 ancestors in all. No later device cites it as a predicate yet.
- Root · 9 generations backK930090 HelicatElscint, Inc. · 1993
- 5 generations between
- 3 generations backK090462 Brilliance Dual Energy OptionPhilips Medical Systems (Cleveland), Inc. · 2009
- 2 generations backK093703 3DIShina Systems, Ltd. · 2010
- 1 generation backK112530 3DI Including CscoreShina Systems, Ltd. · 2011
- This deviceK113442 3DIShina Systems, Ltd. · 2012
Show all 9 generations
- Root · 9 generations backK930090 HelicatElscint, Inc. · 1993
- 8 generations backK961464 Select/SPElscint, Inc. · 1996 · Recalled
- 7 generations backK982060 Volumax CT Imaging SystemElscint, Inc. · 1998
- 6 generations backK012009 MX8000 Idt CT SystemMarconi Medical Systems, Inc. · 2001 · Recalled
- 5 generations backK033326 Philips Plus Computed Tomography SystemPhilips Medical Systems, Inc. · 2003 · Recalled
- 4 generations backK060937 Brilliance VolumePhilips Medical Systems (Cleveland), Inc. · 2006 · Recalled
- 3 generations backK090462 Brilliance Dual Energy OptionPhilips Medical Systems (Cleveland), Inc. · 2009
- 2 generations backK093703 3DIShina Systems, Ltd. · 2010
- 1 generation backK112530 3DI Including CscoreShina Systems, Ltd. · 2011
- This deviceK113442 3DIShina Systems, Ltd. · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K930090 | Helicat | Elscint, Inc. | 1993 | — |
| −8 | K961464 | Select/SP | Elscint, Inc. | 1996 | 3 |
| −7 | K982060 | Volumax CT Imaging System | Elscint, Inc. | 1998 | — |
| −6 | K012009 | MX8000 Idt CT System | Marconi Medical Systems, Inc. | 2001 | 61 |
| −5 | K033326 | Philips Plus Computed Tomography System | Philips Medical Systems, Inc. | 2003 | 131 |
| −4 | K060937 | Brilliance Volume | Philips Medical Systems (Cleveland), Inc. | 2006 | 61 |
| −3 | K090462 | Brilliance Dual Energy Option | Philips Medical Systems (Cleveland), Inc. | 2009 | — |
| −2 | K093703 | 3DI | Shina Systems, Ltd. | 2010 | — |
| −1 | K112530 | 3DI Including Cscore | Shina Systems, Ltd. | 2011 | — |
| 0 (this device) | K113442 | 3DI | Shina Systems, Ltd. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 2 | 0 |
| 1995 | 2 | 0 |
| 1996 | 1 | 0 |
| 1997 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 4 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 2 | 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 |
|---|---|---|---|
| * | K112530 | 3DI Including CscoreSummary page 1…ving and communications system Classification: II Reason for 510(k) Submission Traditional 5 10(k) Submission Identification of Legally Marketed Predicate Devices K112530 3Di Device Description 3Di is a PACS device which enables users to access medical images over a network and to utilize 3Di's imag… | 2011 |
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 19 years and passes through 5 companies; a new generation was cleared every 2.2 years on median.
- 11 of the 29 ancestors have a recall of any class.
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?
3Di is a software package of PACS workstation for handling multimodatity (CT, XA, MR, PET, SPECT, Ultrasound & Mammography) images, which are using DICOM protocol. It includes volume rendering, Multi-planar reconstruction (MPR) and viewing of the inner and outer surfaces of organs as well as within their walls. 3Di is intended for use as an interactive tool for assisting professional Radiologists, Cardiologists and specialists to reach their own…
Read the full statement (117 words)
3Di is a software package of PACS workstation for handling multimodatity (CT, XA, MR, PET, SPECT, Ultrasound & Mammography) images, which are using DICOM protocol. It includes volume rendering, Multi-planar reconstruction (MPR) and viewing of the inner and outer surfaces of organs as well as within their walls.
3Di is intended for use as an interactive tool for assisting professional Radiologists, Cardiologists and specialists to reach their own diagnosis, by providing tools of communication, clinics networking, WEB Serving, image viewing, image manipulation, 2D/3D image visualization, image processing, reporting and archiving. The 3Di indications for use are processing of Cardiac CT studies, including CT Calcium scoring, CT Cardiac angiography, coronaries analysis, cardiac functional assessment and of CT colonoscopy.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K113442 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113442: 3DI.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113442
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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