510(k) · Cleared

Cleared

Bti-Scan, Version 4.0

K051392510(k) TraditionalCleared Jun 29, 200533-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

B.T.I. Biotechnology Institute, Sl. · LLZ System, Image Processing, Radiological

Cleared on Jun 29, 2005 as substantially equivalent to K033849 (Materialise NV, 2004) after a 33-day review. Its family tree reaches back 3 generations to 1993.

Decided: Jun 29, 2005
Review: 33 days
Class: Class II
Product code: LLZ
Recalls: None
Predicates: 1

Its longest line of descent runs back 3 generations to K924630 (1993). 4 ancestors in all, the oldest K924810 (1993). No later device cites it as a predicate yet.

By dateBy generation

Root · 3 generations backK924630 Surgicad (TM) View (TM)Surgicad Corp. · 1993
2 generations backK970617 CT-Modeller SystemMaterialise NV · 1997
1 generation backK033849 Simplant SystemMaterialise NV · 2004
This deviceK051392 Bti-Scan, Version 4.0B.T.I. Biotechnology Institute, Sl. · 2005

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K924630	Surgicad (TM) View (TM)	Surgicad Corp.	1993	—
−2	K970617	CT-Modeller System	Materialise NV	1997	—
−1	K033849	Simplant System	Materialise NV	2004	—
0 (this device)	K051392	Bti-Scan, Version 4.0	B.T.I. Biotechnology Institute, Sl.	2005	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1993	1	0

FIG. 1 — Lineage of K051392, 1993–2005Source: 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

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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
*	K033849	Simplant System Summary page 1 …Class It PREDICATE DEVICE The BTI-Scan is claimed to be substantially equivalent in material, design, and function to the SimPlant System cleared by FDA under 510 (k) K033849 on May 25, 2004 DEVICE DESCRIPTION BTI Scan is intended for use as a software interface and image segmentation system for the t…	Materialise NV	2004	—

Also cleared against K033849: 19 other devices →

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 12 years and passes through 3 companies; a new generation was cleared every 4.0 years on median.
None of the 4 ancestors has a recall.
19 other devices also cite its predicate K033849.

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?

BTI-Scan is indicated for use as a medical front-end software that can be used by medically trained people for the purpose of visualizing gray value images. It is indicated as a software interface and image segmentation system for the transfer of imaging information from a medical CT scanner. It is also indicated for use as a planning and simulation software for dental implant placement and surgical treatment.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K051392 · printed Nov 6, 2026

Cite this page

510(k) Report. “K051392: Bti-Scan, Version 4.0.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051392

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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