510(k) · Cleared

Cleared

C-Insight

K081672510(k) TraditionalCleared Aug 15, 200863-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

Mazor Surgical Technologies, Ltd. · LLZ System, Image Processing, Radiological

Cleared on Aug 15, 2008 as substantially equivalent to K003266 (Siemens Medical Solutions USA, Inc., 2000) and 4 other predicates after a 63-day review. Its family tree reaches back 4 generations to 2000. 1 of the 41 devices in its family, counting itself, has a Class I recall. 33 later devices descend from it.

Decided: Aug 15, 2008
Review: 63 days
Class: Class II
Product code: LLZ
Recalls: None
Predicates: 5

Its longest line of descent runs back 4 generations to K003266 (2000). 7 ancestors in all. 33 later devices descend from it, 2 citing it directly. 1 of the 41 devices in this family, counting this one, has a Class I recall.

By dateBy generation

Root · 4 generations backK003266 Siremobil Iso-C 3DSiemens Medical Solutions USA, Inc. · 2000
3 generations backK032280 Siremobil Iso-C 3DSiemens AG · 2003
2 generations backK050996 O-Arm Imaging SystemBreakaway Imaging, LLC · 2005 · Recalled
1 generation backK060344 O-Arm Imaging SystemBreakaway Imaging, LLC · 2006 · Recalled
This deviceK081672 C-InsightMazor Surgical Technologies, Ltd. · 2008
Descendant · cites it directly · 31 of its ownK102130 Tenzing SystemMazor Surgical Technologies, Ltd. · 2010
Descendant · 2 generations on · 24 of its ownK110911 Renaissance SystemMazor Robotics, Ltd. · 2011
Descendant · 3 generations on · 23 of its ownK113228 Renaissance SystemMazor Robotics, Ltd. · 2011
Descendant · 4 generations on · 21 of its ownK140167 Renaissance X SystemMazor Robotics, Ltd. · 2014
Descendant · 3 generations on · 21 of its ownK120812 RenaissanceMazor Robotics, Ltd. · 2012 · Recalled

Showing 5 of 33 descendants. See all descendants

Descendants cleared per year

2010high 7 (2026) · low 0 (2013)2026

Class I recalls in this family

K003837 Flexiview 8800 Digital Mobile Imaging System2 generations back · 2001

Most influential descendants

Showing 5 of 33 · See all

K102130Tenzing SystemMazor Surgical Technologies, Ltd. · 2010 · cites it directly31descendants
K110911Renaissance SystemMazor Robotics, Ltd. · 2011 · 2 generations on24descendants
K113228Renaissance SystemMazor Robotics, Ltd. · 2011 · 3 generations on23descendants
K140167Renaissance X SystemMazor Robotics, Ltd. · 2014 · 4 generations on21descendants
K120812RenaissanceMazor Robotics, Ltd. · 2012 · 3 generations on21descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−4	K003266	Siremobil Iso-C 3D	Siemens Medical Solutions USA, Inc.	2000	—
−3	K032280	Siremobil Iso-C 3D	Siemens AG	2003	—
−2	K050996	O-Arm Imaging System	Breakaway Imaging, LLC	2005	4
−1	K060344	O-Arm Imaging System	Breakaway Imaging, LLC	2006	1
0 (this device)	K081672	C-Insight	Mazor Surgical Technologies, Ltd.	2008	—
+1	K102130	Tenzing System	Mazor Surgical Technologies, Ltd.	2010	—
+2	K110911	Renaissance System	Mazor Robotics, Ltd.	2011	—
+3	K113228	Renaissance System	Mazor Robotics, Ltd.	2011	—
+4	K140167	Renaissance X System	Mazor Robotics, Ltd.	2014	—
+3	K120812	Renaissance	Mazor Robotics, Ltd.	2012	1

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2001	2	1
2004	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2010	1	0
2011	3	0
2012	1	0
2014	1	0
2015	1	0
2017	2	0
2018	5	0
2020	3	0
2021	1	0
2023	4	0
2024	1	0
2025	3	0
2026	7	0

FIG. 1 — Lineage of K081672, 2000–2026Source: 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.

1 device in this family has a Class I recall. 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? (5)

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
*	K003266	Siremobil Iso-C 3D Summary page 2 …The C-InSightTM system is substantially equivalent to the Siremobil Iso-C 3D software (manufactured by Siemens Medical Systems, Inc. and subject of 510(k) document no. K003266, K032280, K040347) and O-Arm Imaging System software (manufactured by Breakaway Imaging and subject of 510(k) document no. K05099…	Siemens Medical Solutions USA, Inc.	2000	—
*	K032280	Siremobil Iso-C 3D Summary page 2 …nSightTM system is substantially equivalent to the Siremobil Iso-C 3D software (manufactured by Siemens Medical Systems, Inc. and subject of 510(k) document no. K003266, K032280, K040347) and O-Arm Imaging System software (manufactured by Breakaway Imaging and subject of 510(k) document no. K050996 and K06…	Siemens AG	2003	—
*	K040347	Siremobil Iso-C 3D Summary page 2 …system is substantially equivalent to the Siremobil Iso-C 3D software (manufactured by Siemens Medical Systems, Inc. and subject of 510(k) document no. K003266, K032280, K040347) and O-Arm Imaging System software (manufactured by Breakaway Imaging and subject of 510(k) document no. K050996 and K060344). A…	Siemens Medical Systems, Inc.	2004	1
*	K050996	O-Arm Imaging System Summary page 2 …nc. and subject of 510(k) document no. K003266, K032280, K040347) and O-Arm Imaging System software (manufactured by Breakaway Imaging and subject of 510(k) document no. K050996 and K060344). A comparison table and detailed discussion are presented in Section 12 of this application. Device Description:…	Breakaway Imaging, LLC	2005	4
*	K060344	O-Arm Imaging System Summary page 2 …ect of 510(k) document no. K003266, K032280, K040347) and O-Arm Imaging System software (manufactured by Breakaway Imaging and subject of 510(k) document no. K050996 and K060344). A comparison table and detailed discussion are presented in Section 12 of this application. Device Description: C-InSight is…	Breakaway Imaging, LLC	2006	1

Also cleared against K003266: 6 other devices →

What descends from it? (33)

See all 33

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

Number	Device	Applicant	Decided	Descendants
K102130	Tenzing System	Mazor Surgical Technologies, Ltd.	2010	31
K253899	3D-Anywhere	Provect.AI	2026	0

Has anything in its family been recalled? (1 Class I)

No FDA recall names this device.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

K003837Flexiview 8800 Digital Mobile Imaging SystemGe Oec Medical Systems · 2001 · 2 generations back · ◆ in the 2001 ancestors bar of FIG. 11 Class I recall

What does this lineage say?

The line of descent spans 8 years and passes through 4 companies; a new generation was cleared every 2.4 years on median.
5 of the 7 ancestors have a recall of any class; 1 has a Class I recall.
Of its descendants, K102130 (Mazor Surgical Technologies, Ltd., 2010) has gone furthest, with 31 descendants of its own.
6 other devices also cite its predicate K003266.

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. 2008, this device’s year, is highlighted.

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 C-InSight software provides a processing and conversion of 2D fluoroscopic projections from standard C-Arms into volumetric 3D image.

It is intended to be used whenever the clinician and/or patient benefits from generated 3D imaging of high contrast objects particularly for orthopedic applications

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K081672 · printed Nov 4, 2026

Cite this page

510(k) Report. “K081672: C-Insight.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K081672

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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