510(k) · Cleared

Cleared

Multix Compact K and Multix L Radiographic X-Ray Systems

K001201510(k) TraditionalCleared Jun 1, 200049-day reviewClass II21 CFR 892.1680

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. · KPR System, X-Ray, Stationary

Cleared on Jun 1, 2000 after a 49-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 164 later devices descend from it.

Decided: Jun 1, 2000
Review: 49 days
Class: Class II
Product code: KPR
Recalls: None
Predicates: 0

164 later devices descend from it, 3 citing it directly.

This deviceK001201 Multix Compact K and Multix L Radiographic X-Ray SystemsSiemens Medical Solutions USA, Inc. · 2000
Descendant · cites it directly · 158 of its ownK012546 Optima Urs Universal Radiographic SystemSedecal USA, Inc. · 2001 · Recalled
Descendant · 2 generations on · 138 of its ownK042876 Urs LP Digital, Millennium, RadproSedecal., Sa. · 2004
Descendant · 2 generations on · 99 of its ownK062335 Sedecal X Plus LP PlusSedecal., Sa. · 2006
Descendant · 3 generations on · 46 of its ownK090238 Sedecal X-Plus LP Plus Digital Diagnostic X-Ray SystemsSedecal., Sa. · 2009
Descendant · 3 generations on · 41 of its ownK082604 Viztek DR, Models: DR1000, DR3000, DR4000Viztek, Inc. · 2008

Showing 5 of 164 descendants. See all descendants

Descendants cleared per year

2001high 14 (2019) · low 0 (2002)2026

Most influential descendants

Showing 5 of 164 · See all

K012546Optima Urs Universal Radiographic SystemSedecal USA, Inc. · 2001 · cites it directly158descendants
K042876Urs LP Digital, Millennium, RadproSedecal., Sa. · 2004 · 2 generations on138descendants
K062335Sedecal X Plus LP PlusSedecal., Sa. · 2006 · 2 generations on99descendants
K090238Sedecal X-Plus LP Plus Digital Diagnostic X-Ray SystemsSedecal., Sa. · 2009 · 3 generations on46descendants
K082604Viztek DR, Models: DR1000, DR3000, DR4000Viztek, Inc. · 2008 · 3 generations on41descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K001201	Multix Compact K and Multix L Radiographic X-Ray Systems	Siemens Medical Solutions USA, Inc.	2000	—
+1	K012546	Optima Urs Universal Radiographic System	Sedecal USA, Inc.	2001	2
+2	K042876	Urs LP Digital, Millennium, Radpro	Sedecal., Sa.	2004	—
+2	K062335	Sedecal X Plus LP Plus	Sedecal., Sa.	2006	—
+3	K090238	Sedecal X-Plus LP Plus Digital Diagnostic X-Ray Systems	Sedecal., Sa.	2009	—
+3	K082604	Viztek DR, Models: DR1000, DR3000, DR4000	Viztek, Inc.	2008	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2001	2	0
2004	1	0
2005	1	0
2006	2	0
2007	2	0
2008	8	0
2009	3	0
2010	8	0
2011	5	0
2012	8	0
2013	5	0
2014	11	0
2015	10	0
2016	7	0
2017	6	0
2018	7	0
2019	14	0
2020	13	0
2021	9	0
2022	12	0
2023	8	0
2024	5	0
2025	10	0
2026	7	0

FIG. 1 — Lineage of K001201, 2000–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in KPR? 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 KPR device

#1 K242119 Innovision-Exiiscore 17.0 · 9 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (164)

See all 164

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

Number	Device	Applicant	Decided	Descendants
K012546	Optima Urs Universal Radiographic System	Sedecal USA, Inc.	2001	158
K052541	Model HF-50R Computer Controlled X-Ray System	Avant Medical Systems	2005	2
K013218	Fuji Speed Suite, Fuji Speed Sute Phase II	Fujifilm Medical System U.S.A., Inc.	2001	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?

Of its descendants, K012546 (Sedecal USA, Inc., 2001) has gone furthest, with 158 descendants of its own.

How does its category compare?

All KPR devices

KPR System, X-Ray, Stationary: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KPR

8in 2025

2007high 18 (2015) · low 5 (2013)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KPR

155in 2025

2007high 197 (2026) · low 30 (2018)2026

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

Recalls per year · KPR

7in 2025

2007high 10 (2007) · low 0 (2021)2026

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

Adverse event reports per year · KPR

39in 2025

2007high 120 (2007) · low 18 (2016)2025

MAUDE reports naming product code KPR, 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	12	31	10	120
2008	15	48	10	95
2009	9	35	5	61
2010	9	126	3	82
2011	9	152	5	103
2012	11	58	1	74
2013	5	163	5	24
2014	10	108	8	34
2015	18	81	1	59
2016	11	84	4	18
2017	6	75	3	31
2018	15	30	4	36
2019	12	33	1	77
2020	16	39	1	41
2021	6	55	0	37
2022	8	43	2	27
2023	9	76	4	39
2024	11	162	1	34
2025	8	155	7	39
2026	6	197	0	—

https://510kreport.com/device/K001201 · printed Nov 6, 2026

Cite this page

510(k) Report. “K001201: Multix Compact K and Multix L Radiographic X-Ray Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K001201

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Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026