510(k) · Cleared
ClearedGE View Applications (Consisting of GE Viewing Station and GE Extended Viewing Station) Version 1.2C
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ge Medical Systems, Inc. · LLZ System, Image Processing, Radiological
Cleared on Aug 2, 1999 as substantially equivalent to K936179 (Line Imaging Systems, 1994) and 1 other predicate after an 83-day review. Its family tree reaches back 2 generations to 1991.
- Decided
- Aug 2, 1999
- Review
- 83 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K913770 (1991). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 2 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 1 generation backK960613 GE Advantage Windows Review WorkstationGE Medical Systems · 1996
- This deviceK991629 GE View Applications (Consisting of GE Viewing Station and GE…Ge Medical Systems, Inc. · 1999
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K913770 | Advantage V.S. CT/MR Rad Diagnostic Workstation | General Electric Co. | 1991 | — |
| −1 | K960613 | GE Advantage Windows Review Workstation | GE Medical Systems | 1996 | — |
| 0 (this device) | K991629 | GE View Applications (Consisting of GE Viewing Station and GE Extended Viewing… | Ge Medical Systems, Inc. | 1999 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 2 | 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? (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 | Decided |
|---|---|---|---|
| * | K936179 | Winrad Teleradiology SystemSummary page 2…sification Panel: Radiology Product code: LLZ III. Iv. VI Predicate Device General Electric Medical Systems - GE Advantage Review Remote Workstation, K936179. (Cleared as the WinRad Teleradiology System by Line Imaging Systems.) General Electric Medical Systems - GE Advantage Windows D… | 1994 |
| * | K960613 | GE Advantage Windows Review WorkstationSummary page 2…n, K936179. (Cleared as the WinRad Teleradiology System by Line Imaging Systems.) General Electric Medical Systems - GE Advantage Windows Diagnostic Review Workstation, K960613. Device Description GE View Applications is medical image viewing software that consists of two products: the GE Viewing Statio… | 1996 |
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 8 years and passes through 3 companies; a new generation was cleared every 4.3 years on median.
- None of the 4 ancestors has a recall.
- 3 other devices also cite its predicate K936179.
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?
GE View Applications is a medical image viewing software device that allows a user to select, send, receive, and review DICOM images from modalities, such as computed tomography (“CT”), magnetic resonance (“MR”), x-ray (“XR”), nuclear medicine (“NM”), ultra sound (“US”), computed radiography (“CR”), and modalities that generate secondary capture (“SC”) images. GE View Applications is intended to meet different application requirements ranging from simple medical image viewing on the physician’s desktop to clinical image review (e.g., in the ICU).
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/K991629 · printed Nov 4, 2026
Cite this page
510(k) Report. “K991629: GE View Applications (Consisting of GE Viewing Station and GE Extended Viewing Station) Version 1.2C.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K991629
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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