510(k) · Cleared

Recalled · Class II · 2017

Hydradjust IV Urological Table

K943581510(k) TraditionalCleared Jan 4, 1995166-day reviewClass II21 CFR 892.1980Recalls 3

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

Mallinckrodt Group, Inc. · IXR Table, Radiographic, Tilting

Cleared on Jan 4, 1995 after a 166-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 50 later devices descend from it. It has been recalled 3 times.

Decided: Jan 4, 1995
Review: 166 days
Class: Class II
Product code: IXR
Recalls: 3
Predicates: 0

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

This deviceK943581 Hydradjust IV Urological TableMallinckrodt Group, Inc. · 1995
Descendant · cites it directly · 47 of its ownK011311 UrologicPck Electronic Industry and Trade Co, Ltd. · 2001
Descendant · 2 generations on · 45 of its ownK042236 G-SCANEsaote, S.p.A. · 2004
Descendant · 3 generations on · 43 of its ownK060956 G-Scan-Model 9800020000, E-Scan Model 9800010000 and E-Scan…Esaote, S.p.A. · 2006
Descendant · 3 generations on · 34 of its ownK063207 S-Scan Mri SystemEsaote, S.p.A. · 2006
Descendant · 4 generations on · 32 of its ownK061429 Dynamic Mri Software Option for C-Scan, E-Scan XQ and E-Scan OperaEsaote, S.p.A. · 2006

Showing 5 of 50 descendants. See all descendants

Descendants cleared per year

1999high 8 (2012) · low 0 (2000)2026

Most influential descendants

Showing 5 of 50 · See all

K011311UrologicPck Electronic Industry and Trade Co, Ltd. · 2001 · cites it directly47descendants
K042236G-SCANEsaote, S.p.A. · 2004 · 2 generations on45descendants
K060956G-Scan-Model 9800020000, E-Scan Model 9800010000 and E-Scan…Esaote, S.p.A. · 2006 · 3 generations on43descendants
K063207S-Scan Mri SystemEsaote, S.p.A. · 2006 · 3 generations on34descendants
K061429Dynamic Mri Software Option for C-Scan, E-Scan XQ and E-Scan OperaEsaote, S.p.A. · 2006 · 4 generations on32descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K943581	Hydradjust IV Urological Table	Mallinckrodt Group, Inc.	1995	—
+1	K011311	Urologic	Pck Electronic Industry and Trade Co, Ltd.	2001	—
+2	K042236	G-SCAN	Esaote, S.p.A.	2004	—
+3	K060956	G-Scan-Model 9800020000, E-Scan Model 9800010000 and E-Scan…	Esaote, S.p.A.	2006	—
+3	K063207	S-Scan Mri System	Esaote, S.p.A.	2006	—
+4	K061429	Dynamic Mri Software Option for C-Scan, E-Scan XQ and E-Scan Opera	Esaote, S.p.A.	2006	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1999	1	0
2001	1	0
2004	1	0
2005	2	0
2006	3	0
2008	4	0
2009	2	0
2010	2	0
2011	4	0
2012	8	0
2013	3	0
2015	4	0
2016	3	0
2017	1	0
2019	4	0
2021	1	0
2022	1	0
2024	2	0
2026	3	0

FIG. 1 — Lineage of K943581, 1995–2026Source: 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 IXR? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Candidate predicates for a device like this, rankedin the report
Recall history across each candidate’s familyin the report

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What was it cleared against?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (50)

See all 50

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

Number	Device	Applicant	Decided	Descendants
K011311	Urologic	Pck Electronic Industry and Trade Co, Ltd.	2001	47
K121838	Liebel-Flarsheim Direct Digital Imaging System	Liebel-Flarsheim	2012	0
K993687	Uroview 2800	Ge Dec Medical Systems	1999	0

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
Feb 27, 2017	Class II	Z-2833-2018	Radiation Control for Health and Safety Act	Software issue. The difference between the display and dosimeter readings In the Child/Pediatric automatic exposure mode is in the range of 52-65%. The display in all other modes deviated by less than 35% from the dosimeter readings.
Apr 25, 2013	Class II	Z-1753-2013	Employee error	A complaint was received in which a hospital physicist indicated the dosage was too high on the HUT system. During the service call the systems Maximum Fluoro Dose was found to be 30 R/min which is three times the Maximum Fluoro Dose…
Jun 14, 2010	Not classified	Z-1904-2010	Process control	Covidien received complaints of the Sedecal Generator failing and producing smoke at customer sites. The failure modes are located in different parts of the generator and will lead to the generator becoming inoperative.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Of its descendants, K011311 (Pck Electronic Industry and Trade Co, Ltd., 2001) has gone furthest, with 47 descendants of its own.

How does its category compare?

All IXR devices

IXR Table, Radiographic, Tilting: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · IXR

FDA has decided no IXR device since 2007.

Median 510(k) review, days · IXR

Too few IXR 510(k)s in any year since 2007 to give a median.

Recalls per year · IXR

1in 2025

2007high 5 (2010) · low 0 (2009)2026

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

Adverse event reports per year · IXR

1in 2024

2007high 196 (2013) · low 0 (2025)2025

MAUDE reports naming product code IXR, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	—	1	4
2008	—	4	8
2009	—	0	1
2010	—	5	12
2011	—	0	10
2012	—	0	164
2013	—	0	196
2014	—	0	120
2015	—	0	82
2016	—	1	58
2017	—	1	25
2018	—	0	17
2019	—	1	8
2020	—	0	12
2021	—	0	5
2022	—	0	2
2023	—	0	1
2024	—	0	1
2025	—	1	0
2026	—	0	—

https://510kreport.com/device/K943581 · printed Nov 6, 2026

Cite this page

510(k) Report. “K943581: Hydradjust IV Urological Table.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K943581

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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