510(k) · Cleared

Recalled · 2003

Multix U. Bucky Table X-Ray Unit

K803130510(k) TraditionalCleared Jan 28, 198147-day reviewClass II21 CFR 892.1680Recalls 1

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

Siemens Corp. · KPR System, X-Ray, Stationary

Cleared on Jan 28, 1981 after a 47-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 198 later devices descend from it. It has been recalled once.

Decided: Jan 28, 1981
Review: 47 days
Class: Class II
Product code: KPR
Recalls: 1
Predicates: 0

198 later devices descend from it, 1 citing it directly.

This deviceK803130 Multix U. Bucky Table X-Ray UnitSiemens Corp. · 1981
Descendant · cites it directly · 197 of its ownK971452 Multix Top/Pro Radiographic X-Ray TableSiemens Medical Solutions USA, Inc. · 1997 · Recalled
Descendant · 2 generations on · 187 of its ownK983732 Thorax FD and Multix FDSiemens Medical Solutions USA, Inc. · 1999 · Recalled
Descendant · 3 generations on · 103 of its ownK992794 Stingray DR, Model 1Infimed, Inc. · 1999
Descendant · 3 generations on · 81 of its ownK013826 Axiom Aristos FX (Multi Purpose Radiography System)Siemens Medical Systems, Inc. · 2002 · Recalled
Descendant · 4 generations on · 80 of its ownK061054 Axiom Aristos FX PlusSiemens Medical Solutions USA, Inc. · 2006 · Recalled

Showing 5 of 198 descendants. See all descendants

Descendants cleared per year

1997high 14 (2019) · low 0 (1998)2026

Most influential descendants

Showing 5 of 198 · See all

K971452Multix Top/Pro Radiographic X-Ray TableSiemens Medical Solutions USA, Inc. · 1997 · cites it directly197descendants
K983732Thorax FD and Multix FDSiemens Medical Solutions USA, Inc. · 1999 · 2 generations on187descendants
K992794Stingray DR, Model 1Infimed, Inc. · 1999 · 3 generations on103descendants
K013826Axiom Aristos FX (Multi Purpose Radiography System)Siemens Medical Systems, Inc. · 2002 · 3 generations on81descendants
K061054Axiom Aristos FX PlusSiemens Medical Solutions USA, Inc. · 2006 · 4 generations on80descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K803130	Multix U. Bucky Table X-Ray Unit	Siemens Corp.	1981	—
+1	K971452	Multix Top/Pro Radiographic X-Ray Table	Siemens Medical Solutions USA, Inc.	1997	8
+2	K983732	Thorax FD and Multix FD	Siemens Medical Solutions USA, Inc.	1999	1
+3	K992794	Stingray DR, Model 1	Infimed, Inc.	1999	—
+3	K013826	Axiom Aristos FX (Multi Purpose Radiography System)	Siemens Medical Systems, Inc.	2002	8
+4	K061054	Axiom Aristos FX Plus	Siemens Medical Solutions USA, Inc.	2006	3

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1997	1	0
1999	2	0
2001	1	0
2002	1	0
2003	1	0
2005	1	0
2006	3	0
2007	4	0
2008	6	0
2009	4	0
2010	9	0
2011	9	0
2012	7	0
2013	11	0
2014	12	0
2015	12	0
2016	13	0
2017	10	0
2018	8	0
2019	14	0
2020	14	0
2021	14	0
2022	9	0
2023	8	0
2024	7	0
2025	9	0
2026	8	0

FIG. 1 — Lineage of K803130, 1981–2026Source: 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

Get a 510(k) Report

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? (198)

See all 198

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

Number	Device	Applicant	Decided	Descendants
K971452	Multix Top/Pro Radiographic X-Ray Table	Siemens Medical Solutions USA, Inc.	1997	197

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Apr 15, 2003	Not classified	Z-0987-03	Other	the back up safety catch may not function properly

No ancestor or descendant has a Class I recall.

What does this lineage say?

Of its descendants, K971452 (Siemens Medical Solutions USA, Inc., 1997) has gone furthest, with 197 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/K803130 · printed Nov 6, 2026

Cite this page

510(k) Report. “K803130: Multix U. Bucky Table X-Ray Unit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K803130

Report an extraction error

Are you the manufacturer?

Record history

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