510(k) · Cleared

Cleared

Sedecal X Plus LP Plus

K062335510(k) SpecialCleared Sep 14, 200635-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

Sedecal., Sa. · KPR System, X-Ray, Stationary

Cleared on Sep 14, 2006 as substantially equivalent to K012546 (Sedecal USA, Inc., 2001) after a 35-day review. Its family tree reaches back 2 generations to 2000. 99 later devices descend from it.

Decided: Sep 14, 2006
Review: 35 days
Class: Class II
Product code: KPR
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K001201 (2000). 99 later devices descend from it, 5 citing it directly.

By dateBy generation

Root · 2 generations backK001201 Multix Compact K and Multix L Radiographic X-Ray SystemsSiemens Medical Solutions USA, Inc. · 2000
1 generation backK012546 Optima Urs Universal Radiographic SystemSedecal USA, Inc. · 2001 · Recalled
This deviceK062335 Sedecal X Plus LP PlusSedecal., Sa. · 2006
Descendant · cites it directly · 46 of its ownK090238 Sedecal X-Plus LP Plus Digital Diagnostic X-Ray SystemsSedecal., Sa. · 2009
Descendant · 2 generations on · 18 of its ownK092830 Digital X-Ray Imaging System, Model DRC-1000VATECH Co., Ltd. · 2010
Descendant · 2 generations on · 17 of its ownK102408 Digital Diagnostic X-Ray SystemDRGEM Corporation · 2010
Descendant · 3 generations on · 17 of its ownK091090 Digital Flat Panel X-Ray Detector, Model Xmaru 1717E-Woo Technology · 2010
Descendant · cites it directly · 17 of its ownK090279 Sedecal, Millennium PlusSedecal., Sa. · 2009

Showing 5 of 99 descendants. See all descendants

Descendants cleared per year

2006high 9 (2015) · low 0 (2007)2026

Most influential descendants

Showing 5 of 99 · See all

K090238Sedecal X-Plus LP Plus Digital Diagnostic X-Ray SystemsSedecal., Sa. · 2009 · cites it directly46descendants
K092830Digital X-Ray Imaging System, Model DRC-1000VATECH Co., Ltd. · 2010 · 2 generations on18descendants
K102408Digital Diagnostic X-Ray SystemDRGEM Corporation · 2010 · 2 generations on17descendants
K091090Digital Flat Panel X-Ray Detector, Model Xmaru 1717E-Woo Technology · 2010 · 3 generations on17descendants
K090279Sedecal, Millennium PlusSedecal., Sa. · 2009 · cites it directly17descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	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
0 (this device)	K062335	Sedecal X Plus LP Plus	Sedecal., Sa.	2006	—
+1	K090238	Sedecal X-Plus LP Plus Digital Diagnostic X-Ray Systems	Sedecal., Sa.	2009	—
+2	K092830	Digital X-Ray Imaging System, Model DRC-1000	VATECH Co., Ltd.	2010	—
+2	K102408	Digital Diagnostic X-Ray System	DRGEM Corporation	2010	—
+3	K091090	Digital Flat Panel X-Ray Detector, Model Xmaru 1717	E-Woo Technology	2010	—
+1	K090279	Sedecal, Millennium Plus	Sedecal., Sa.	2009	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2006	1	0
2008	2	0
2009	2	0
2010	6	0
2011	2	0
2012	5	0
2013	4	0
2014	7	0
2015	9	0
2016	4	0
2017	2	0
2018	4	0
2019	8	0
2020	7	0
2021	5	0
2022	4	0
2023	8	0
2024	5	0
2025	8	0
2026	6	0

FIG. 1 — Lineage of K062335, 2000–2026Source: 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.

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? (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
*	K012546	Optima Urs Universal Radiographic System Summary page 1 …Product Codes Product Code 90 KPR Commion/Usual Name: General purpose diagnostic X-ray Unit. 2. Equivalent legally marketed devices: Sedecal URS X-Ray Units K012546. 3. Indications for Use (intended use) The SEDECAL X PLUS LP PLUS Universal Radio~graphic Systems are intended fbr…	Sedecal USA, Inc.	2001	2

Also cleared against K012546: 6 other devices →

What descends from it? (99)

See all 99

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

Number	Device	Applicant	Decided	Descendants
K090238	Sedecal X-Plus LP Plus Digital Diagnostic X-Ray Systems	Sedecal., Sa.	2009	46
K090279	Sedecal, Millennium Plus	Sedecal., Sa.	2009	17
K080582	Medicatech, Model DDR Mak-800, DDT Mak-1000 FS, DDR Mak-1100 FA	Medicatech USA	2008	16
K063283	Definium 5000 X-Ray System	Sedecal., Sa.	2006	14
K103050	DX-D 300	Agfa Healthcare N.V.	2010	8

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 6 years and passes through 3 companies; a new generation was cleared every 4.9 years on median.
1 of the 2 ancestors has a recall of any class.
Of its descendants, K090238 (Sedecal., Sa., 2009) has gone furthest, with 46 descendants of its own.
6 other devices also cite its predicate K012546.

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	—

What is it indicated for?

The SEDECAL X PLUS LP PLUS Universal Radiographic Systems are intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K062335 · printed Nov 6, 2026

Cite this page

510(k) Report. “K062335: Sedecal X Plus LP Plus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K062335

Report an extraction error

Are you the manufacturer?

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