510(k) · Cleared

Recalled · Class II · 2012

CT Colonography/NAVIGATOR2

K012313510(k) TraditionalCleared Aug 7, 200115-day reviewClass II21 CFR 892.1750Recalls 1

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

Ge Medical Systems, Inc. · JAK System, X-Ray, Tomography, Computed

Cleared on Aug 7, 2001 as substantially equivalent to K954355 (General Electric Co., 1995) after a 15-day review. Its family tree reaches back 1 generation to 1995. 1 of the 582 devices in its family, counting itself, has a Class I recall. 580 later devices descend from it. It has been recalled once.

Decided: Aug 7, 2001
Review: 15 days
Class: Class II
Product code: JAK
Recalls: 1
Predicates: 1

Its longest line of descent runs back 1 generation to K954355 (1995). 580 later devices descend from it, 3 citing it directly. 1 of the 582 devices in this family, counting this one, has a Class I recall.

By dateBy generation

Root · 1 generation backK954355 Advantage Windows 3D with Navigator OptionGeneral Electric Co. · 1995
This deviceK012313 CT Colonography/NAVIGATOR2Ge Medical Systems, Inc. · 2001
Descendant · cites it directly · 469 of its ownK041521 Volume Viewer PlusGeneral Electric Medical Systems · 2004 · Recalled
Descendant · cites it directly · 227 of its ownK030982 Syngo Colonography Software PackageSiemens Medical Solutions USA, Inc. · 2003
Descendant · 2 generations on · 217 of its ownK061696 Iqqa-Liver SoftwareEdda Technology, Inc. · 2006
Descendant · 2 generations on · 210 of its ownK033102 Medic Colon Model, Release 1Medicsight · 2003
Descendant · 3 generations on · 209 of its ownK042674 Colon Car 1.2Medicsight · 2004

Showing 5 of 580 descendants. See all descendants

Descendants cleared per year

2003high 53 (2025) · low 3 (2003)2026

Class I recalls in this family

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

Most influential descendants

Showing 5 of 580 · See all

K041521Volume Viewer PlusGeneral Electric Medical Systems · 2004 · cites it directly469descendants
K030982Syngo Colonography Software PackageSiemens Medical Solutions USA, Inc. · 2003 · cites it directly227descendants
K061696Iqqa-Liver SoftwareEdda Technology, Inc. · 2006 · 2 generations on217descendants
K033102Medic Colon Model, Release 1Medicsight · 2003 · 2 generations on210descendants
K042674Colon Car 1.2Medicsight · 2004 · 3 generations on209descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K954355	Advantage Windows 3D with Navigator Option	General Electric Co.	1995	—
0 (this device)	K012313	CT Colonography/NAVIGATOR2	Ge Medical Systems, Inc.	2001	—
+1	K041521	Volume Viewer Plus	General Electric Medical Systems	2004	2
+1	K030982	Syngo Colonography Software Package	Siemens Medical Solutions USA, Inc.	2003	—
+2	K061696	Iqqa-Liver Software	Edda Technology, Inc.	2006	—
+2	K033102	Medic Colon Model, Release 1	Medicsight	2003	—
+3	K042674	Colon Car 1.2	Medicsight	2004	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2003	3	0
2004	4	0
2005	3	0
2006	6	0
2007	5	0
2008	6	0
2009	8	0
2010	9	0
2011	12	0
2012	17	0
2013	16	0
2014	21	0
2015	19	0
2016	22	0
2017	28	0
2018	41	0
2019	36	0
2020	45	0
2021	43	0
2022	44	0
2023	42	0
2024	50	0
2025	53	1
2026	47	0

FIG. 1 — Lineage of K012313, 1995–2026Source: 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 JAK device

#1 K230223 iCAC Devicescore 23.5 · 12 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
*	K954355	Advantage Windows 3D with Navigator Option Summary page 1 …lonography/Navigator2 is substantially equivalent to the device listed below: Model: Navigator _ Manufacturer: General Electric Medical Systems, Milwaukee, WI 510(k) #: K954355 Device Description: CT Colonography/Navigator2 (CTC/Nav2) is an image analysis software package that allows the user to study t…	General Electric Co.	1995	—

Also cleared against K954355: 9 other devices →

What descends from it? (580)

See all 580

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

Number	Device	Applicant	Decided	Descendants
K041521	Volume Viewer Plus	General Electric Medical Systems	2004	469
K030982	Syngo Colonography Software Package	Siemens Medical Solutions USA, Inc.	2003	227
K023943	CT Colonography	Ge Medical Systems, Inc.	2003	3

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
May 24, 2012	Class II	Z-1960-2012	Software design	GE Healthcare has become aware of a potential safety issue due to incorrect alignment of fused CT and PET images associated with the CT/PET fusion capabilities of your Volume Viewer and CT/PET Fusion application. Volume Viewer allows two…

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?

Its one ancestor has no recall.
Of its descendants, K041521 (General Electric Medical Systems, 2004) has gone furthest, with 469 descendants of its own.
9 other devices also cite its predicate K954355.

How does its category compare?

All JAK devices

JAK System, X-Ray, Tomography, Computed: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JAK

27in 2025

2007high 30 (2014) · low 7 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JAK

141in 2025

2007high 200 (2014) · low 27 (2007)2026

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

Recalls per year · JAK

17in 2025

2007high 51 (2010) · low 5 (2019)2026

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

Adverse event reports per year · JAK

219in 2025

2007high 543 (2018) · low 76 (2007)2025

MAUDE reports naming product code JAK, 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	14	27	11	76
2008	26	42	16	120
2009	15	31	29	105
2010	7	92	51	119
2011	16	155	34	205
2012	28	121	23	192
2013	17	132	11	414
2014	30	200	10	308
2015	30	140	28	454
2016	25	129	44	365
2017	29	96	33	338
2018	24	114	10	543
2019	28	94	5	233
2020	30	112	8	177
2021	20	145	15	261
2022	30	131	9	199
2023	27	139	9	310
2024	26	141	20	212
2025	27	141	17	219
2026	21	167	23	—

What is it indicated for?

CT Colonography/Navigator2 is an image analysis software package that contains CT Colonogarphy and Navigator2. CT Colonography allows the user to study the inside, wall and outside of the colon. It provides the user with an ability to view datasets from both, prone and supine positions, facilitating detection of colonic lesions. In comparison to colonoscopy, this tool has an advantage of non-invasive depth penetration due to its 3D presentation…

Read the full statement (155 words)

CT Colonography/Navigator2 is an image analysis software package that contains CT

Colonogarphy and Navigator2.

CT Colonography allows the user to study the inside, wall and outside of the colon. It

provides the user with an ability to view datasets from both, prone and supine positions,

facilitating detection of colonic lesions. In comparison to colonoscopy, this tool has an

advantage of non-invasive depth penetration due to its 3D presentation capability.

Navigator2 provides endoluminal views of anatomical structures. Navigator2 is designed

to enhance and modify current image quality, tools, speed and user interface of Navigator for

improved productivity. Navigator2 provides a visualization tool to investigate structures (such as

polyps, tumors, stones, calcification etc.) within anatomy, airways and organs. Thus, its

viewing capability of the inner and outer surfaces of organs as well as within their walls provides

additional supplemental information, complementing endoscopy/colonoscopy, to support

interpretation and treatment planning. Navigation2 is applicable to X-ray as well as CT/MR.

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/K012313 · printed Nov 5, 2026

Cite this page

510(k) Report. “K012313: CT Colonography/NAVIGATOR2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K012313

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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