510(k) · Cleared
Recalled · Class II · 2021Scanip; Scanip: Medical Edition; Scanip: Med
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Simpleware, Ltd. · LLZ System, Image Processing, Radiological
Cleared on Apr 17, 2015 as substantially equivalent to K073468 (Materialise NV, 2008) after a 203-day review. Its family tree reaches back 4 generations to 1993. 4 later devices descend from it. It has been recalled 2 times.
- Decided
- Apr 17, 2015
- Review
- 203 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 4 generations to K924630 (1993). 5 ancestors in all, the oldest K924810 (1993). 4 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK924630 Surgicad (TM) View (TM)Surgicad Corp. · 1993
- 3 generations backK970617 CT-Modeller SystemMaterialise NV · 1997
- 2 generations backK033849 Simplant SystemMaterialise NV · 2004
- 1 generation backK073468 MimicsMaterialise NV · 2008
- This deviceK142779 Scanip; Scanip: Medical Edition; Scanip: MedSimpleware, Ltd. · 2015
- Descendant · cites it directly · 3 of its ownK203195 Simpleware ScanIP MedicalSynopsys (Northern Europe), Ltd. · 2021
- Descendant · 2 generations on · 1 of its ownK221796 Cyware 4H and Cysart 4HAbys Medical · 2022
- Descendant · 3 generations on · 0 of its ownK243069 Lumys (V1)Intradys · 2025
- Descendant · 2 generations on · 0 of its ownK241961 Vent Creativity Knee v1.0 (Hermes)Vent Creativity · 2025
Most influential descendants
Showing 4 of 4 · See all- K203195Simpleware ScanIP MedicalSynopsys (Northern Europe), Ltd. · 2021 · cites it directly3descendants
- K221796Cyware 4H and Cysart 4HAbys Medical · 2022 · 2 generations on1descendant
- K243069Lumys (V1)Intradys · 2025 · 3 generations on0descendants
- K241961Vent Creativity Knee v1.0 (Hermes)Vent Creativity · 2025 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K924630 | Surgicad (TM) View (TM) | Surgicad Corp. | 1993 | — |
| −3 | K970617 | CT-Modeller System | Materialise NV | 1997 | — |
| −2 | K033849 | Simplant System | Materialise NV | 2004 | — |
| −1 | K073468 | Mimics | Materialise NV | 2008 | — |
| 0 (this device) | K142779 | Scanip; Scanip: Medical Edition; Scanip: Med | Simpleware, Ltd. | 2015 | — |
| +1 | K203195 | Simpleware ScanIP Medical | Synopsys (Northern Europe), Ltd. | 2021 | — |
| +2 | K221796 | Cyware 4H and Cysart 4H | Abys Medical | 2022 | — |
| +3 | K243069 | Lumys (V1) | Intradys | 2025 | — |
| +2 | K241961 | Vent Creativity Knee v1.0 (Hermes) | Vent Creativity | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2025 | 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 |
|---|---|---|---|
| * | K073468 | MimicsSummary page 4…ss: II Product Code: LLZ III. PREDICATE DEVICE Manufacturer_____________Device________________ 510(k) Number Materialise N.V. Mimics K073468 No reference devices were used in this submission. IV. Device Description ScanIP represents a software interf… | 2008 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K203195 | Simpleware ScanIP Medical | 2021 | 3 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 4, 2021 | Class II | Z-2254-2021 | Software Manufacturing/Software Deployment | A issue (bug) has been identified with the interface and image software which could result in anatomical orientation tags/labels being displayed incorrectly. This could result in operator misunderstanding and errors during resampling or… |
| Jun 4, 2021 | Class II | Z-2253-2021 | Software Manufacturing/Software Deployment | A issue (bug) has been identified with the interface and image software which could result in anatomical orientation tags/labels being displayed incorrectly. This could result in operator misunderstanding and errors during resampling or… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 22 years and passes through 3 companies; a new generation was cleared every 7.0 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K203195 (Synopsys (Northern Europe), Ltd., 2021) has gone furthest, with 3 descendants of its own.
- 8 other devices also cite its predicate K073468.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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?
ScanIP is intended for use as a software interface and image segmentation system for the transfer of imaging information
from a medical scanner such as a CT scanner or a Magnetic Resonance Imaging scanner to an output file. It is also intended as pre-operative software for simulating/evaluating surgical treatment options. ScanIP is not intended to be used for mammography imaging.
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/K142779 · printed Nov 6, 2026
Cite this page
510(k) Report. “K142779: Scanip; Scanip: Medical Edition; Scanip: Med.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K142779
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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