510(k) · Cleared
Recalled · Class II · 2024Viewpoint 6
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
GE Healthcare · LLZ System, Image Processing, Radiological
Cleared on Mar 4, 2011 as substantially equivalent to K050943 (General Electric Co., 2005) after a 101-day review. Its family tree reaches back 6 generations to 1995. 1 later device descends from it. It has been recalled 2 times.
- Decided
- Mar 4, 2011
- Review
- 101 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 6 generations to K950279 (1995). 10 ancestors in all, the oldest K925965 (1993). 1 later device descends from it, 1 citing it directly.
- Root · 6 generations backK950279 TOMTECP90Tomtec Imaging Systems, Inc. · 1995
- 5 generations backK964803 Univision Echocardiology SystemNetwork Concepts, Inc. · 1997
- 4 generations backK980060 EcholinkMpacs, LLC · 1998
- 3 generations backK992259 Echocardiography System Series 95000Camtronics, Ltd. · 1999
- 2 generations backK041029 KinetdxSiemens Medi Cal Solutions, Inc. · 2004 · Recalled
- 1 generation backK050943 GE ViewpointGeneral Electric Co. · 2005 · Recalled
- This deviceK103458 Viewpoint 6GE Healthcare · 2011
- Descendant · cites it directly · 0 of its ownK162743 ViewPoint 6GE Medical Systems Ultrasound and Primary Care Diagnostics · 2016 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K162743ViewPoint 6GE Medical Systems Ultrasound and Primary Care Diagnostics · 2016 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K950279 | TOMTECP90 | Tomtec Imaging Systems, Inc. | 1995 | — |
| −5 | K964803 | Univision Echocardiology System | Network Concepts, Inc. | 1997 | — |
| −4 | K980060 | Echolink | Mpacs, LLC | 1998 | — |
| −3 | K992259 | Echocardiography System Series 95000 | Camtronics, Ltd. | 1999 | — |
| −2 | K041029 | Kinetdx | Siemens Medi Cal Solutions, Inc. | 2004 | 1 |
| −1 | K050943 | GE Viewpoint | General Electric Co. | 2005 | 1 |
| 0 (this device) | K103458 | Viewpoint 6 | GE Healthcare | 2011 | — |
| +1 | K162743 | ViewPoint 6 | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2016 | 1 |
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 |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K050943 | GE ViewpointSummary page 1…Classification Names: PACS - Picture archiving and communications system Prod uct Code: LLZ, 892.2050 Predicate Device(s): ViewPoint5 [(050943] .5-2… | 2005 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K162743 | ViewPoint 6 | 2016 | 0 |
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-3146-2024 | 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… |
| Aug 7, 2013 | Class II | Z-2098-2013 | Software Design Change | GE has recently become aware of a potential safety issue due to the incorrect calculation of the pulsatility index value (PIV) for venous flow measurements associated with obstetric reporting of the GE ViewPoint 6 system. The ViewPoint… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 16 years and passes through 7 companies; a new generation was cleared every 1.5 years on median.
- 3 of the 10 ancestors have a recall of any class.
- Of its descendants, K162743 (GE Medical Systems Ultrasound and Primary Care Diagnostics, 2016) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K050943.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
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?
ViewPoint is intended to be used in medical practices and in clinical departments and serves the purposes of diagnostic interpretation of images, electronic documentation of examinations in the form of text and images and generation of medical reports primarily for diagnostic ultrasound. ViewPoint provides the user the ability to include images, drawings, and charts into medical reports. ViewPoint is designed to accept, transfer, display, calculate…
Read the full statement (128 words)
ViewPoint is intended to be used in medical practices and in clinical departments and serves the purposes of diagnostic interpretation of images, electronic documentation of examinations in the form of text and images and generation of medical reports primarily for diagnostic ultrasound. ViewPoint provides the user the ability to include images, drawings, and charts into medical reports. ViewPoint is designed to accept, transfer, display, calculate, store and process medical images and data, and enables the user to measure and annotate the images. The medical images, which ViewPoint displays to the user, can be used for diagnostic purposes.
ViewPoint is intended for professional use only. ViewPoint is not intended to be used as an automated diagnosis system.
Viewpoint is not intended to operate medical devices in surgery related procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K103458 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103458: Viewpoint 6.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103458
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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