510(k) · Cleared

Cleared

CT-Modeller System

K970617510(k) TraditionalCleared Apr 21, 199762-day reviewClass II21 CFR 892.2050

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Materialise NV · LLZ System, Image Processing, Radiological

Cleared on Apr 21, 1997 as substantially equivalent to K924630 (Surgicad Corp., 1993) after a 62-day review. Its family tree reaches back 1 generation to 1993. 380 later devices descend from it.

Decided: Apr 21, 1997
Review: 62 days
Class: Class II
Product code: LLZ
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K924630 (1993). 380 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 1 generation backK924630 Surgicad (TM) View (TM)Surgicad Corp. · 1993
This deviceK970617 CT-Modeller SystemMaterialise NV · 1997
Descendant · cites it directly · 379 of its ownK033849 Simplant SystemMaterialise NV · 2004
Descendant · 2 generations on · 143 of its ownK073449 SurgicaseMaterialise NV · 2008
Descendant · 2 generations on · 141 of its ownK073468 MimicsMaterialise NV · 2008
Descendant · 3 generations on · 99 of its ownK102795 Signature Planner; Signature GuidesMaterialise NV · 2011 · Recalled
Descendant · 3 generations on · 71 of its ownK111863 Signature Planner,Signature GuidesMaterialise NV · 2012

Showing 5 of 380 descendants. See all descendants

Descendants cleared per year

2004high 43 (2023) · low 2 (2004)2026

Most influential descendants

Showing 5 of 380 · See all

K033849Simplant SystemMaterialise NV · 2004 · cites it directly379descendants
K073449SurgicaseMaterialise NV · 2008 · 2 generations on143descendants
K073468MimicsMaterialise NV · 2008 · 2 generations on141descendants
K102795Signature Planner; Signature GuidesMaterialise NV · 2011 · 3 generations on99descendants
K111863Signature Planner,Signature GuidesMaterialise NV · 2012 · 3 generations on71descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K924630	Surgicad (TM) View (TM)	Surgicad Corp.	1993	—
0 (this device)	K970617	CT-Modeller System	Materialise NV	1997	—
+1	K033849	Simplant System	Materialise NV	2004	—
+2	K073449	Surgicase	Materialise NV	2008	—
+2	K073468	Mimics	Materialise NV	2008	—
+3	K102795	Signature Planner; Signature Guides	Materialise NV	2011	4
+3	K111863	Signature Planner,Signature Guides	Materialise NV	2012	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2004	2	0
2005	3	0
2006	6	0
2007	4	0
2008	3	0
2009	3	0
2010	2	0
2011	9	0
2012	12	0
2013	16	0
2014	13	0
2015	12	0
2016	17	0
2017	22	0
2018	20	0
2019	23	0
2020	29	0
2021	24	0
2022	26	0
2023	43	0
2024	25	0
2025	33	0
2026	33	0

FIG. 1 — Lineage of K970617, 1993–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

Get a 510(k) 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	Applicant	Decided	Recalls
*	K924630	Surgicad (TM) View (TM) Summary page 1 …DICATE DEVICE The CT-Modeller System is claimed to be substantially equivalent in material, design, and function to the SurgiCAD View System cleared by FDA under 510(k) K924630 on Apnl 7, 1993. II. __ Device Description The Materialise CT-Modeller System is intended for use as a software interface and im…	Surgicad Corp.	1993	—

Also cleared against K924630: 1 other device →

What descends from it? (380)

See all 380

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K033849	Simplant System	Materialise NV	2004	379
K120956	VSP System	Medical Modeling, Inc.	2012	28

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?

Its one ancestor has no recall.
Of its descendants, K033849 (Materialise NV, 2004) has gone furthest, with 379 descendants of its own.
1 other device also cites its predicate K924630.

How does its category compare?

All LLZ devices

LLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LLZ

58in 2025

2007high 106 (2011) · low 51 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LLZ

173in 2025

2007high 173 (2025) · low 36 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · LLZ

11in 2025

2007high 64 (2013) · low 2 (2019)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · LLZ

116in 2025

2007high 15,631 (2014) · low 26 (2023)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?

The Materialise CT-Modeller System 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 Magnetic Resonance imaging scanner or CT scanner. The input

data file is processed by the CT-Modeller System and the result is an output data file

which may then be used as input data for a CAD or Rapid Prototyping System. The

CT-Modeller System which is the subject of this 510(k) premarket notification is

confined solely to the software image segmentation system.

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/K970617 · printed Nov 5, 2026

Cite this page

510(k) Report. “K970617: CT-Modeller System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K970617

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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