510(k) · Cleared

Cleared

Fly Through

K971717510(k) TraditionalCleared Sep 3, 1997117-day reviewClass II21 CFR 892.1750

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

Siemens Medical Solutions USA, Inc. · JAK System, X-Ray, Tomography, Computed

Cleared on Sep 3, 1997 after a 117-day review. The FDA summary names its predicate without a number. 1 of the 229 devices in its family, counting itself, has a Class I recall. 228 later devices descend from it.

Decided: Sep 3, 1997
Review: 117 days
Class: Class II
Product code: JAK
Recalls: None
Predicates: 0

228 later devices descend from it, 3 citing it directly. 1 of the 229 devices in this family, counting this one, has a Class I recall.

This deviceK971717 Fly ThroughSiemens Medical Solutions USA, Inc. · 1997
Descendant · cites it directly · 227 of its ownK030982 Syngo Colonography Software PackageSiemens Medical Solutions USA, Inc. · 2003
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
Descendant · 4 generations on · 134 of its ownK061214 Aquariusaps ServerTerarecon,Inc. · 2006
Descendant · 5 generations on · 99 of its ownK112020 Syngo.CT Vascular AnalysisSiemens Medi Cal Solutions, Inc. · 2011

Showing 5 of 228 descendants. See all descendants

Descendants cleared per year

2003high 22 (2024) · low 0 (2007)2026

Class I recalls in this family

K250443 MAGNETOM Avanto Fit; MAGNETOM Skyra Fit…9 generations on · 2025

Most influential descendants

Showing 5 of 228 · See all

K030982Syngo Colonography Software PackageSiemens Medical Solutions USA, Inc. · 2003 · cites it directly227descendants
K033102Medic Colon Model, Release 1Medicsight · 2003 · 2 generations on210descendants
K042674Colon Car 1.2Medicsight · 2004 · 3 generations on209descendants
K061214Aquariusaps ServerTerarecon,Inc. · 2006 · 4 generations on134descendants
K112020Syngo.CT Vascular AnalysisSiemens Medi Cal Solutions, Inc. · 2011 · 5 generations on99descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K971717	Fly Through	Siemens Medical Solutions USA, Inc.	1997	—
+1	K030982	Syngo Colonography Software Package	Siemens Medical Solutions USA, Inc.	2003	—
+2	K033102	Medic Colon Model, Release 1	Medicsight	2003	—
+3	K042674	Colon Car 1.2	Medicsight	2004	—
+4	K061214	Aquariusaps Server	Terarecon,Inc.	2006	—
+5	K112020	Syngo.CT Vascular Analysis	Siemens Medi Cal Solutions, Inc.	2011	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2003	2	0
2004	2	0
2005	1	0
2006	1	0
2008	1	0
2009	3	0
2010	2	0
2011	2	0
2012	4	0
2013	5	0
2014	3	0
2015	3	0
2016	4	0
2017	13	0
2018	19	0
2019	20	0
2020	20	0
2021	17	0
2022	20	0
2023	21	0
2024	22	0
2025	22	1
2026	21	0

FIG. 1 — Lineage of K971717, 1997–2026Source: 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? (2)

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
*	—	Advantage Windows 3D with Navigator Named without a submission number			—
*	—	Prominence Workstation (Silhouette) Named without a submission number			—

What descends from it? (228)

See all 228

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

Number	Device	Applicant	Decided	Descendants
K030982	Syngo Colonography Software Package	Siemens Medical Solutions USA, Inc.	2003	227
K052963	Mediq Version 1.0	Clario Medical Imaging, Inc.	2005	11
K173625	syngo.CT Clinical Extensions	Siemens Medical Solutions USA, Inc.	2018	5

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 · 9 generations on · ◆ in the 2025 descendants bar of FIG. 12 Class I recalls

What does this lineage say?

Of its descendants, K030982 (Siemens Medical Solutions USA, Inc., 2003) has gone furthest, with 227 descendants of its own.

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?

From user specified sets of CT or MR images, Fly Through can be used for 3D presentation of segmented anatomic models (e.g., tracheas, bones, vessels, colon, etc.); navigating interactively through 3D segmented models that represent body cavities (e.g., vessels, colon, spine, lung, etc.); for viewing the inner surface of organ models (vessels, colon, etc.). Fly Through offers advantages over real endoscopy. For example, Fly Through can be performed…

Read the full statement (136 words)

From user specified sets of CT or MR images, Fly Through can be used for

3D presentation of segmented anatomic models (e.g., tracheas, bones, vessels, colon, etc.);

navigating interactively through 3D segmented models that represent body cavities (e.g., vessels, colon, spine, lung, etc.);

for viewing the inner surface of organ models (vessels, colon, etc.). Fly Through offers advantages over real endoscopy. For example, Fly Through can be performed within models of organs or blood vessels inaccessible to a real endoscope;

a training tool for surgeons to practice endoscopic procedures;

surgical planning;

feasibility study of an actual endoscopic procedure; and

a 3D positioning and orientation tool for Multiplanar reconstruction, thus assisting diagnosis from Multi-Planar-Reconstructions (MPRs): the Fly Through tool can help the user to position and visualize the 3-dimensional location of the MPR within the segmented dataset.

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/K971717 · printed Nov 4, 2026

Cite this page

510(k) Report. “K971717: Fly Through.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K971717

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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