510(k) · Cleared
Recalled · Class II · 2024GE Viewpoint
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
General Electric Co. · LLZ System, Image Processing, Radiological
Cleared on May 23, 2005 as substantially equivalent to K041029 (Siemens Medi Cal Solutions, Inc., 2004) after a 39-day review. Its family tree reaches back 5 generations to 1995. 3 later devices descend from it. It has been recalled once.
- Decided
- May 23, 2005
- Review
- 39 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 5 generations to K950279 (1995). 9 ancestors in all, the oldest K925965 (1993). 3 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK950279 TOMTECP90Tomtec Imaging Systems, Inc. · 1995
- 4 generations backK964803 Univision Echocardiology SystemNetwork Concepts, Inc. · 1997
- 3 generations backK980060 EcholinkMpacs, LLC · 1998
- 2 generations backK992259 Echocardiography System Series 95000Camtronics, Ltd. · 1999
- 1 generation backK041029 KinetdxSiemens Medi Cal Solutions, Inc. · 2004 · Recalled
- This deviceK050943 GE ViewpointGeneral Electric Co. · 2005
- Descendant · cites it directly · 1 of its ownK103458 Viewpoint 6GE Healthcare · 2011 · Recalled
- Descendant · 2 generations on · 0 of its ownK162743 ViewPoint 6GE Medical Systems Ultrasound and Primary Care Diagnostics · 2016 · Recalled
- Descendant · cites it directly · 0 of its ownK101166 4D-View 9.1 (4D View PC Software) Model: H48651SZGE Healthcare · 2010
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K950279 | TOMTECP90 | Tomtec Imaging Systems, Inc. | 1995 | — |
| −4 | K964803 | Univision Echocardiology System | Network Concepts, Inc. | 1997 | — |
| −3 | K980060 | Echolink | Mpacs, LLC | 1998 | — |
| −2 | K992259 | Echocardiography System Series 95000 | Camtronics, Ltd. | 1999 | — |
| −1 | K041029 | Kinetdx | Siemens Medi Cal Solutions, Inc. | 2004 | 1 |
| 0 (this device) | K050943 | GE Viewpoint | General Electric Co. | 2005 | — |
| +1 | K103458 | Viewpoint 6 | GE Healthcare | 2011 | 2 |
| +2 | K162743 | ViewPoint 6 | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2016 | 1 |
| +1 | K101166 | 4D-View 9.1 (4D View PC Software) Model: H48651SZ | GE Healthcare | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1996 | 2 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2016 | 1 | 0 |
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
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 | Decided |
|---|---|---|---|
| * | K041029 | KinetdxSummary page 1…ing System System, Image Processing, Radiological , 21 CFR 892.2050, 90-LLZ 3. Marketed Device: KinetDx@ Diagnostic Workstation for Radiology - K041 029, 6/8/2004, 90-LLZ Currently placed in commercial distribution by Siemens Medical Solutions. 4. Devce es… | 2004 |
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 8, 2024 | Class II | Z-3145-2024 | Device Design | The National Institute of Standards and Technology (NIST) has identified in the National Vulnerability Database (NVD) that NexGen Healthcare Mirth Connect, prior to version 4.4.1, has a potential vulnerability allowing the deserialization… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 10 years and passes through 6 companies; a new generation was cleared every 1.4 years on median.
- 2 of the 9 ancestors have a recall of any class.
- Of its descendants, K103458 (GE Healthcare, 2011) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K041029.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LLZ
58in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LLZ
173in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LLZ
11in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LLZ
116in 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 GE ViewPoint is intended to accept, transfer, display, store and process medical images and data, including the ability to measure, calculate, annotate and prepare and print patient examination reports primarily for diagnostic ultrasound.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K050943 · printed Nov 5, 2026
Cite this page
510(k) Report. “K050943: GE Viewpoint.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K050943
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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