510(k) · Cleared

Cleared

CTC Workstation, Model 2200

K062229510(k) TraditionalCleared Sep 11, 200640-day reviewClass II21 CFR 892.2050

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

Medical Diagnostic Technologies, Inc. · LLZ System, Image Processing, Radiological

Cleared on Sep 11, 2006 as substantially equivalent to K024028 (Context Vision AB, 2003) and 3 other predicates after a 40-day review. Its family tree reaches back 5 generations to 1990.

Decided: Sep 11, 2006
Review: 40 days
Class: Class II
Product code: LLZ
Recalls: None
Predicates: 4

Its longest line of descent runs back 5 generations to K896095 (1990). 16 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 5 generations backK896095 Images-on-Call Teleradiology SystemDevices & Services Co. · 1990
4 generations backK962699 Radworks Medical Imaging SoftwareApplicare Medical Imaging, B.V. · 1996
3 generations backK982862 Radworks Medical Imaging Software with Quality Control ModuleApplicare Medical Imaging, B.V. · 1998
2 generations backK012211 Efilm WorkstationEfilm Medical, Inc. · 2001 · Recalled
1 generation backK052411 Hipax Medical Imaging SoftwareSteinhart Medizinsysteme GmbH · 2005
This deviceK062229 CTC Workstation, Model 2200Medical Diagnostic Technologies, Inc. · 2006

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−5	K896095	Images-on-Call Teleradiology System	Devices & Services Co.	1990	—
−4	K962699	Radworks Medical Imaging Software	Applicare Medical Imaging, B.V.	1996	—
−3	K982862	Radworks Medical Imaging Software with Quality Control Module	Applicare Medical Imaging, B.V.	1998	—
−2	K012211	Efilm Workstation	Efilm Medical, Inc.	2001	1
−1	K052411	Hipax Medical Imaging Software	Steinhart Medizinsysteme GmbH	2005	—
0 (this device)	K062229	CTC Workstation, Model 2200	Medical Diagnostic Technologies, Inc.	2006	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1991	1	0
1992	1	0
1993	1	0
1995	1	0
1996	2	0
1997	1	0
1998	1	0
2000	1	0
2002	1	0
2003	1	0

FIG. 1 — Lineage of K062229, 1990–2006Source: 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 LLZ? 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 LLZ device

#1 K230955 syngo Application Softwarescore 21.5 · 11 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? (4)

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
*	K024028	Sharp View Image Enhancement System Summary page 1 …e enhancement/processing system Classification: LLZ; Class II; CFR 21 892.2050 Predicate Devices: K # & Device Name Manufacturer K024028/K993802 SharpView/GOPView ContextVision AB K023772 KinetDx Siemens K05241 1 HIPAX…	Context Vision AB	2003	—
*	K993802	Sharpview Image Enhancement System Summary page 1 …ement/processing system Classification: LLZ; Class II; CFR 21 892.2050 Predicate Devices: K # & Device Name Manufacturer K024028/K993802 SharpView/GOPView ContextVision AB K023772 KinetDx Siemens K05241 1 HIPAX…	Context Vision AB	2000	—
*	K023772	Kinetdx Picture Archiving and Communications System Summary page 1 …II; CFR 21 892.2050 Predicate Devices: K # & Device Name Manufacturer K024028/K993802 SharpView/GOPView ContextVision AB K023772 KinetDx Siemens K05241 1 HIPAX Steinhart Medizinsystemne Desc…	Acuson Corp.	2002	5
*	K052411	Hipax Medical Imaging Software Summary page 1 …me Manufacturer K024028/K993802 SharpView/GOPView ContextVision AB K023772 KinetDx Siemens K05241 1 HIPAX Steinhart Medizinsystemne Description of Device: Under the direction of the physician th…	Steinhart Medizinsysteme GmbH	2005	—

Also cleared against K024028: 6 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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 16 years and passes through 5 companies; a new generation was cleared every 2.8 years on median.
2 of the 16 ancestors have a recall of any class.
6 other devices also cite its predicate K024028.

How does its category compare?

All LLZ devices

LLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LLZ

58in 2025

2007high 106 (2011) · low 51 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LLZ

173in 2025

2007high 173 (2025) · low 36 (2007)2026

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

Recalls per year · LLZ

11in 2025

2007high 64 (2013) · low 2 (2019)2026

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

Adverse event reports per year · LLZ

116in 2025

2007high 15,631 (2014) · low 26 (2023)2025

MAUDE reports naming product code LLZ, 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	76	36	20	152
2008	94	52	32	154
2009	70	62	21	145
2010	51	98	17	145
2011	106	79	30	454
2012	82	87	12	266
2013	95	84	64	1,130
2014	78	89	6	15,631
2015	64	90	16	211
2016	82	90	12	290
2017	78	107	5	104
2018	104	105	7	72
2019	74	107	2	88
2020	81	115	6	82
2021	83	116	3	70
2022	65	137	4	28
2023	87	157	8	26
2024	62	131	6	42
2025	58	173	11	116
2026	45	110	14	—

What is it indicated for?

The CTC Workstation system is intended for use by a qualified physician to direct the storage, display, enhancement, and viewing of ultrasound images.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K062229 · printed Nov 4, 2026

Cite this page

510(k) Report. “K062229: CTC Workstation, Model 2200.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K062229

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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