510(k) · Cleared

Cleared

Suresubtraction Ortho

K130960510(k) TraditionalCleared Aug 20, 2013137-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

Toshibamedical Systems Corporation · JAK System, X-Ray, Tomography, Computed

Cleared on Aug 20, 2013 as substantially equivalent to K051833 (Toshiba America Medical Systems, In.C, 2005) and 1 other predicate after a 137-day review. Its family tree reaches back 3 generations to 2003. 3 later devices descend from it.

Decided: Aug 20, 2013
Review: 137 days
Class: Class II
Product code: JAK
Recalls: None
Predicates: 2

Its longest line of descent runs back 3 generations to K031469 (2003). 5 ancestors in all. 3 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 3 generations backK031469 Aquilion Super 4 Multislice CT Scanner, Model TSX-101A/7Toshiba America Medical Systems, In.C · 2003 · Recalled
2 generations backK033418 TSX-101A/a and TSX-101A/C Aquilion Multislice CT ScannersToshiba America Medical Systems, In.C · 2003 · Recalled
1 generation backK051833 TSX-101A/H Aquilion 64 SP CT Scanner; TSX-101A/I Aquilion 32 SP CT…Toshiba America Medical Systems, In.C · 2005
This deviceK130960 Suresubtraction OrthoToshibamedical Systems Corporation · 2013
Descendant · cites it directly · 2 of its ownK151212 Ziostation2Qi Imaging, LLC · 2015
Descendant · 2 generations on · 1 of its ownK181892 Ziostation2Ziosoft, Inc. · 2018
Descendant · 3 generations on · 0 of its ownK200315 Ziostation2Ziosoft, Inc. · 2020

Most influential descendants

Showing 3 of 3 · See all

K151212Ziostation2Qi Imaging, LLC · 2015 · cites it directly2descendants
K181892Ziostation2Ziosoft, Inc. · 2018 · 2 generations on1descendant
K200315Ziostation2Ziosoft, Inc. · 2020 · 3 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K031469	Aquilion Super 4 Multislice CT Scanner, Model TSX-101A/7	Toshiba America Medical Systems, In.C	2003	1
−2	K033418	TSX-101A/a and TSX-101A/C Aquilion Multislice CT Scanners	Toshiba America Medical Systems, In.C	2003	2
−1	K051833	TSX-101A/H Aquilion 64 SP CT Scanner; TSX-101A/I Aquilion 32 SP CT Scanner	Toshiba America Medical Systems, In.C	2005	—
0 (this device)	K130960	Suresubtraction Ortho	Toshibamedical Systems Corporation	2013	—
+1	K151212	Ziostation2	Qi Imaging, LLC	2015	—
+2	K181892	Ziostation2	Ziosoft, Inc.	2018	—
+3	K200315	Ziostation2	Ziosoft, Inc.	2020	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2012	2	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2015	1	0
2018	1	0
2020	1	0

FIG. 1 — Lineage of K130960, 2003–2020Source: 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 JAK? 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
*	K051833	TSX-101A/H Aquilion 64 SP CT Scanner; TSX-101A/I Aquilion 32 SP CT Scanner Summary page 2 …Orbital Synchronized Scan System, CKOS-OO1 A, which was originally cleared under the premarket notification for TSX-1O1AIH, /1,Aquilion 64/32 SP CT Scanner 510(k), K051833. Since this clearance all Toshiba CT systems have incorporated this post processing software; the latest clearance being…	Toshiba America Medical Systems, In.C	2005	—
*	K122109	Aquilion One Vision, V4.90 Summary page 2 …this clearance all Toshiba CT systems have incorporated this post processing software; the latest clearance being on the Aquilion ONE Vision, TSX-301c/1, v4.90, K122 109. SlJRESubtraction Ortho includes modifications to the predicate software which improves on the anatomical region with which…	Toshiba America Medical Systems, In.C	2012	1

Also cleared against K051833: 2 other devices →

What descends from it? (3)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K151212	Ziostation2	Qi Imaging, LLC	2015	2

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 10 years and passes through 2 companies; a new generation was cleared every 1.7 years on median.
4 of the 5 ancestors have a recall of any class.
Of its descendants, K151212 (Qi Imaging, LLC, 2015) has gone furthest, with 2 descendants of its own.
2 other devices also cite its predicate K051833.

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. 2013, this device’s year, is highlighted.

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?

SURSubtradtion Ortho software is intended to generate subtraction images and improve the visualization of contrast enhancement. The system can load two or more CT images with and without contrast enhancement. When used by a qualified physician, a potential application is to determine the course of treatment.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K130960 · printed Nov 3, 2026

Cite this page

510(k) Report. “K130960: Suresubtraction Ortho.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K130960

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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