510(k) · Cleared

Cleared

R2 Family of Image Display Units with R2 Uniform Display Software

K050667510(k) TraditionalCleared Mar 29, 200514-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

R2 Technology, Inc. · LLZ System, Image Processing, Radiological

Cleared on Mar 29, 2005 as substantially equivalent to K023003 (R2 Technology, Inc., 2002) and 3 other predicates after a 14-day review. Its family tree reaches back 5 generations to 1991.

Decided: Mar 29, 2005
Review: 14 days
Class: Class II
Product code: LLZ
Recalls: None
Predicates: 4

Its longest line of descent runs back 5 generations to K913475 (1991). 18 ancestors in all, the oldest K800751 (1980). No later device cites it as a predicate yet.

By dateBy generation

Root · 5 generations backK913475 Magnetic Resonance Diagnostic DeviceGE Medical Systems · 1991
4 generations backK960265 Advantage Windows with Functool OptionGE Medical Systems · 1996 · Recalled
3 generations backK971965 Philips EasyvisionPhilips Medical Systems, Inc. · 1998
2 generations backK022292 Impax Diagnostic Display Station,Impax Clinical Review Station,Impax…Agfa Corp. · 2002 · Recalled
1 generation backK031248 Consultiva Report Station, Model RS-1Miramedica, Inc. · 2003
This deviceK050667 R2 Family of Image Display Units with R2 Uniform Display SoftwareR2 Technology, Inc. · 2005

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−5	K913475	Magnetic Resonance Diagnostic Device	GE Medical Systems	1991	—
−4	K960265	Advantage Windows with Functool Option	GE Medical Systems	1996	1
−3	K971965	Philips Easyvision	Philips Medical Systems, Inc.	1998	—
−2	K022292	Impax Diagnostic Display Station,Impax Clinical Review Station,Impax for…	Agfa Corp.	2002	9
−1	K031248	Consultiva Report Station, Model RS-1	Miramedica, Inc.	2003	—
0 (this device)	K050667	R2 Family of Image Display Units with R2 Uniform Display Software	R2 Technology, Inc.	2005	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1980	1	0
1991	1	0
1994	2	0
1996	1	0
1997	1	0
1998	1	0
2000	1	0
2001	1	0
2002	3	0
2004	1	0

FIG. 1 — Lineage of K050667, 1991–2005Source: 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
*	K023003	Imagechecker-CT Workstation Summary page 1 …Common Name: Medical Imaging Workstation Classification: LLZ; Class II; CFR 21 892.2050 Predicate Devices: K023003 R2 CT ImageChecker for CT K042697 ICAD Second Look Viewer…	R2 Technology, Inc.	2002	—
*	K042697	Second Look Viewer Summary page 1 …: LLZ; Class II; CFR 21 892.2050 Predicate Devices: K023003 R2 CT ImageChecker for CT K042697 ICAD Second Look Viewer K031248 MiraMedica Consultiva…	Icad, Inc.	2004	—
*	K031248	Consultiva Report Station, Model RS-1 Summary page 1 …K023003 R2 CT ImageChecker for CT K042697 ICAD Second Look Viewer K031248 MiraMedica Consultiva K800751 RadX, Mammolux Changers Description of Dev…	Miramedica, Inc.	2003	—
*	K800751	Radx Vent-AL Mechanical Resporator Summary page 1 …K042697 ICAD Second Look Viewer K031248 MiraMedica Consultiva K800751 RadX, Mammolux Changers Description of Device: The R2 family of Image Display Units are a combination of dedicated com…	Radx Corp.	1980	—

Also cleared against K023003: 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 14 years and passes through 5 companies; a new generation was cleared every 1.8 years on median.
3 of the 18 ancestors have a recall of any class.
6 other devices also cite its predicate K023003.

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 family of R2 Image Display Units with UDS software is intended to display low resolution, non-diagnostic medical images with annotations such as pre-computed regions-of-interest or pre-computed CAD marks from medical scanning devices.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K050667 · printed Nov 6, 2026

Cite this page

510(k) Report. “K050667: R2 Family of Image Display Units with R2 Uniform Display Software.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050667

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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