510(k) · Cleared

Cleared

Urologic

K011311510(k) TraditionalCleared Jul 10, 200171-day reviewClass II21 CFR 892.1650

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

Pck Electronic Industry and Trade Co, Ltd. · OWB Interventional Fluoroscopic X-Ray System

Cleared on Jul 10, 2001 as substantially equivalent to K940295 (Ge Dec Medical Systems, 1994) and 1 other predicate after a 71-day review. Its family tree reaches back 1 generation to 1994. 47 later devices descend from it.

Decided: Jul 10, 2001
Review: 71 days
Class: Class II
Product code: OWB
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K940295 (1994). 2 ancestors in all. 47 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 1 generation backK940295 Uroview Model 2600Ge Dec Medical Systems · 1994 · Recalled
This deviceK011311 UrologicPck Electronic Industry and Trade Co, Ltd. · 2001
Descendant · cites it directly · 45 of its ownK042236 G-SCANEsaote, S.p.A. · 2004
Descendant · 2 generations on · 43 of its ownK060956 G-Scan-Model 9800020000, E-Scan Model 9800010000 and E-Scan…Esaote, S.p.A. · 2006
Descendant · 2 generations on · 34 of its ownK063207 S-Scan Mri SystemEsaote, S.p.A. · 2006
Descendant · 3 generations on · 32 of its ownK061429 Dynamic Mri Software Option for C-Scan, E-Scan XQ and E-Scan OperaEsaote, S.p.A. · 2006
Descendant · 2 generations on · 24 of its ownK080968 S-Scan, G-Scan, Dynamic Mri Software for C-Scan, E-Scanxq & E-Scan…Esaote, S.p.A. · 2008

Showing 5 of 47 descendants. See all descendants

Descendants cleared per year

2004high 7 (2012) · low 0 (2007)2026

Most influential descendants

Showing 5 of 47 · See all

K042236G-SCANEsaote, S.p.A. · 2004 · cites it directly45descendants
K060956G-Scan-Model 9800020000, E-Scan Model 9800010000 and E-Scan…Esaote, S.p.A. · 2006 · 2 generations on43descendants
K063207S-Scan Mri SystemEsaote, S.p.A. · 2006 · 2 generations on34descendants
K061429Dynamic Mri Software Option for C-Scan, E-Scan XQ and E-Scan OperaEsaote, S.p.A. · 2006 · 3 generations on32descendants
K080968S-Scan, G-Scan, Dynamic Mri Software for C-Scan, E-Scanxq & E-Scan OperaEsaote, S.p.A. · 2008 · 2 generations on24descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K940295	Uroview Model 2600	Ge Dec Medical Systems	1994	1
0 (this device)	K011311	Urologic	Pck Electronic Industry and Trade Co, Ltd.	2001	—
+1	K042236	G-SCAN	Esaote, S.p.A.	2004	—
+2	K060956	G-Scan-Model 9800020000, E-Scan Model 9800010000 and E-Scan…	Esaote, S.p.A.	2006	—
+2	K063207	S-Scan Mri System	Esaote, S.p.A.	2006	—
+3	K061429	Dynamic Mri Software Option for C-Scan, E-Scan XQ and E-Scan Opera	Esaote, S.p.A.	2006	—
+2	K080968	S-Scan, G-Scan, Dynamic Mri Software for C-Scan, E-Scanxq & E-Scan Opera	Esaote, S.p.A.	2008	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1995	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2004	1	0
2005	2	0
2006	3	0
2008	4	0
2009	2	0
2010	2	0
2011	4	0
2012	7	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 K011311, 1994–2026Source: 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 OWB? 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 OWB device

#1 K251602 Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6…score 18.3 · 18 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? (2)

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
*	K940295	Uroview Model 2600 Summary page 2 …ication UROVogic 3. Substantial Equivalence The UROlogic Urological Table is substantially equivalent to the following currently marketed devices: ¢ OEC Uroview 2600 (K940295) e Liebel-Flarsheim Hydradjust IV (K943581) 4. Description of Device UROlogic is a universal fluoroscopic x-ray diagnostic syst…	Ge Dec Medical Systems	1994	1
*	K943581	Hydradjust IV Urological Table Summary page 2 …e The UROlogic Urological Table is substantially equivalent to the following currently marketed devices: ¢ OEC Uroview 2600 (K940295) e Liebel-Flarsheim Hydradjust IV (K943581) 4. Description of Device UROlogic is a universal fluoroscopic x-ray diagnostic system intended for use in providing x-ray imag…	Mallinckrodt Group, Inc.	1995	3

Also cleared against K940295: 1 other device →

What descends from it? (47)

See all 47

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

Number	Device	Applicant	Decided	Descendants
K042236	G-SCAN	Esaote, S.p.A.	2004	45
K053279	Urovantage	Pck Electronic Industry & Trade Co., Ltd.	2005	0

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?

2 of the 2 ancestors have a recall of any class.
Of its descendants, K042236 (Esaote, S.p.A., 2004) has gone furthest, with 45 descendants of its own.
1 other device also cites its predicate K940295.

How does its category compare?

All OWB devices

OWB Interventional Fluoroscopic X-Ray System: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · OWB

22in 2025

2007high 24 (2021) · low 3 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · OWB

148in 2025

2007high 221 (2026) · low 37 (2012)2026

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

Recalls per year · OWB

42so far in 2026, the most since 2007

2007high 42 (2026) · low 0 (2007)2026

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

Adverse event reports per year · OWB

14,008in 2025

2007high 14,008 (2025) · low 0 (2008)2025

MAUDE reports naming product code OWB, 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	3	52	0	1
2008	4	135	1	0
2009	9	99	0	0
2010	7	66	0	0
2011	6	79	0	1
2012	6	37	0	1
2013	11	119	10	27
2014	15	158	9	103
2015	11	66	35	2,134
2016	16	103	13	4,074
2017	20	76	13	1,604
2018	23	54	6	1,449
2019	9	174	7	1,558
2020	16	53	8	1,581
2021	24	60	31	1,981
2022	21	90	24	2,932
2023	12	152	22	7,604
2024	13	126	11	7,942
2025	22	148	30	14,008
2026	15	221	42	—

What is it indicated for?

UROlogic is intended to provide fluoroscopic and radiographic imaging of the

patient during diagnostic, surgical and interventional procedures

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K011311 · printed Nov 6, 2026

Cite this page

510(k) Report. “K011311: Urologic.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K011311

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026