510(k) · Cleared

Cleared

Voxar VC, Model 1.0

K012072510(k) TraditionalCleared Jul 12, 200110-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

Voxar Limited · LLZ System, Image Processing, Radiological

Cleared on Jul 12, 2001 after a 10-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 1 of the 220 devices in its family, counting itself, has a Class I recall. 219 later devices descend from it.

Decided: Jul 12, 2001
Review: 10 days
Class: Class II
Product code: LLZ
Recalls: None
Predicates: 0

219 later devices descend from it, 3 citing it directly. 1 of the 220 devices in this family, counting this one, has a Class I recall.

This deviceK012072 Voxar VC, Model 1.0Voxar Limited · 2001
Descendant · cites it directly · 210 of its ownK033102 Medic Colon Model, Release 1Medicsight · 2003
Descendant · 2 generations on · 209 of its ownK042674 Colon Car 1.2Medicsight · 2004
Descendant · 3 generations on · 134 of its ownK061214 Aquariusaps ServerTerarecon,Inc. · 2006
Descendant · 4 generations on · 99 of its ownK112020 Syngo.CT Vascular AnalysisSiemens Medi Cal Solutions, Inc. · 2011
Descendant · 3 generations on · 70 of its ownK083423 Coloncad Api 3.1Medicsight Plc · 2011

Showing 5 of 219 descendants. See all descendants

Descendants cleared per year

2002high 21 (2025) · low 0 (2005)2026

Class I recalls in this family

K250443 MAGNETOM Avanto Fit; MAGNETOM Skyra Fit…8 generations on · 2025

Most influential descendants

Showing 5 of 219 · See all

K033102Medic Colon Model, Release 1Medicsight · 2003 · cites it directly210descendants
K042674Colon Car 1.2Medicsight · 2004 · 2 generations on209descendants
K061214Aquariusaps ServerTerarecon,Inc. · 2006 · 3 generations on134descendants
K112020Syngo.CT Vascular AnalysisSiemens Medi Cal Solutions, Inc. · 2011 · 4 generations on99descendants
K083423Coloncad Api 3.1Medicsight Plc · 2011 · 3 generations on70descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K012072	Voxar VC, Model 1.0	Voxar Limited	2001	—
+1	K033102	Medic Colon Model, Release 1	Medicsight	2003	—
+2	K042674	Colon Car 1.2	Medicsight	2004	—
+3	K061214	Aquariusaps Server	Terarecon,Inc.	2006	—
+4	K112020	Syngo.CT Vascular Analysis	Siemens Medi Cal Solutions, Inc.	2011	—
+3	K083423	Coloncad Api 3.1	Medicsight Plc	2011	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2002	1	0
2003	2	0
2004	3	0
2006	2	0
2009	1	0
2010	2	0
2011	2	0
2012	4	0
2013	6	0
2014	2	0
2015	3	0
2016	4	0
2017	12	0
2018	19	0
2019	20	0
2020	20	0
2021	16	0
2022	20	0
2023	20	0
2024	20	0
2025	21	1
2026	19	0

FIG. 1 — Lineage of K012072, 2001–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?

FDA’s file for it is a 510(k) statement, which names no predicate.

What descends from it? (219)

See all 219

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

Number	Device	Applicant	Decided	Descendants
K033102	Medic Colon Model, Release 1	Medicsight	2003	210
K020658	Viatronix V3D Colon	Viatronix, Inc.	2002	4
K040126	Viatronix V3D Colon, Revision 1.3	Viatronix, Inc.	2004	2

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.

K250443MAGNETOM Avanto Fit; MAGNETOM Skyra Fit; MAGNETOM Sola Fit; MAGNETOM Viato.MobileSiemens Healthcare GmbH · 2025 · 8 generations on · ◆ in the 2025 descendants bar of FIG. 12 Class I recalls

What does this lineage say?

Of its descendants, K033102 (Medicsight, 2003) has gone furthest, with 210 descendants of its own.

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?

Voxar Colonscreen is a software application for the display and 3D visualization of medical image data derived from CT and MR scans for the purpose of assisting in patient review and detection of colon polyps, cancers and other lesions by providing display and reporting facilities to enhance workflow. It is intended for use by radiologists, clinicians and referring physicians to process, render, review, store, print and distribute DICOM 3.0 compliant image studies, utilizing standard PC hardware.

Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K012072 · printed Nov 5, 2026

Cite this page

510(k) Report. “K012072: Voxar VC, Model 1.0.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K012072

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026