510(k) · Cleared

Cleared

Safire

K103424510(k) TraditionalCleared Nov 22, 2011365-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 Nov 22, 2011 as substantially equivalent to K082220 (Siemens Medical Solutions USA, Inc., 2008) after a 365-day review. Its family tree reaches back 5 generations to 2001. 2 later devices descend from it.

Decided: Nov 22, 2011
Review: 365 days
Class: Class II
Product code: JAK
Recalls: None
Predicates: 1

Its longest line of descent runs back 5 generations to K013561 (2001). 10 ancestors in all, the oldest K982349 (1998). 2 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 5 generations backK013561 Lightspeed 4.0 CT Scanner SystemGE Medical Systems · 2001 · Recalled
4 generations backK030420 Lightspeed 5.0 Computed Tomography SystemGE Medical Systems · 2003 · Recalled
3 generations backK040372 Lightspeed 7.0 CT Scanner SystemGe Medical Systems, LLC · 2004 · Recalled
2 generations backK052216 Somatom DefinitionSiemens Medical Systems, Inc. · 2005
1 generation backK082220 Somatom Flash DSSiemens Medical Solutions USA, Inc. · 2008
This deviceK103424 SafireSiemens Medical Solutions USA, Inc. · 2011
Descendant · cites it directly · 1 of its ownK133646 AdmireSiemens Medical Systems, Inc. · 2014
Descendant · 2 generations on · 0 of its ownK153360 AdmireSiemens Medi Cal Solutions, Inc. · 2016

Most influential descendants

Showing 2 of 2 · See all

K133646AdmireSiemens Medical Systems, Inc. · 2014 · cites it directly1descendant
K153360AdmireSiemens Medi Cal Solutions, Inc. · 2016 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−5	K013561	Lightspeed 4.0 CT Scanner System	GE Medical Systems	2001	5
−4	K030420	Lightspeed 5.0 Computed Tomography System	GE Medical Systems	2003	4
−3	K040372	Lightspeed 7.0 CT Scanner System	Ge Medical Systems, LLC	2004	5
−2	K052216	Somatom Definition	Siemens Medical Systems, Inc.	2005	—
−1	K082220	Somatom Flash DS	Siemens Medical Solutions USA, Inc.	2008	—
0 (this device)	K103424	Safire	Siemens Medical Solutions USA, Inc.	2011	—
+1	K133646	Admire	Siemens Medical Systems, Inc.	2014	—
+2	K153360	Admire	Siemens Medi Cal Solutions, Inc.	2016	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1998	1	0
2001	1	0
2004	1	0
2006	1	0
2008	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2014	1	0
2016	1	0

FIG. 1 — Lineage of K103424, 2001–2016Source: 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? (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
*	K082220	Somatom Flash DS Summary page 2 …ial distribution Predicate Device Name FDA Clearance Number FDA Clearance Date SOMA TOM Definition Flash K082220 1/020 7. Summary of Technological Characteristics of the Principal Device as Compared with th…	Siemens Medical Solutions USA, Inc.	2008	—

Also cleared against K082220: 2 other devices →

What descends from it? (2)

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

Number	Device	Applicant	Decided	Descendants
K133646	Admire	Siemens Medical Systems, Inc.	2014	1

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 4 companies; a new generation was cleared every 1.5 years on median.
6 of the 10 ancestors have a recall of any class.
Of its descendants, K133646 (Siemens Medical Systems, Inc., 2014) has gone furthest, with 1 descendant of its own.
2 other devices also cite its predicate K082220.

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. 2011, 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?

SAFIRE is a CT reconstmuction software. The end user can choose to apply either SAFIRE or the weighted filter back-projection (WFSP) to the acquired raw data. Depending on the clinical task, patient size, anatomical location, and clinical practice, the use of SAFIRE can help to reduce radiation dose while maintaining Pixel noise, low contrast dletectability and high contrast resolution. Phantom irieasuremnents showed that high contrast resolution and…

Read the full statement (164 words)

SAFIRE is a CT reconstmuction software. The end user can choose to apply either SAFIRE or the weighted filter back-projection (WFSP) to the acquired raw data.

Depending on the clinical task, patient size, anatomical location, and clinical practice, the use of SAFIRE can help to reduce radiation dose while maintaining Pixel noise, low contrast dletectability and high contrast resolution. Phantom irieasuremnents showed that high contrast resolution and pixel noise are equivalent between full dose WFBP images and reduced dose SAFIRE images. Additionally, SAFIRE can reduce spiral artifacts by using iterations going back and forth between image space and raw data space. A Model Observer evaluation showed that equivalent low contrast detectability can be achieved with 54% to 60% less dose using SAFIRE at highest noise reduction strength for thin (0.6 mm) reconstruction slices in simulated body and head phantoms for low contrast objects with different contrasts. Images reconstructed with SAFIRE are not intended to be evaluated with syngo Osten CT or syngo Calcium Scoring.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K103424 · printed Nov 6, 2026

Cite this page

510(k) Report. “K103424: Safire.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103424

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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