510(k) · Cleared
ClearedQ-Station
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Philips Ultrasound, Inc. · LLZ System, Image Processing, Radiological
Cleared on Jan 25, 2011 as substantially equivalent to K061995 (Philips Medical Systems North America Co., 2006) after a 27-day review. Its family tree reaches back 5 generations to 1996. 1 later device descends from it.
- Decided
- Jan 25, 2011
- Review
- 27 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K954479 (1996). 10 ancestors in all, the oldest K954668 (1995). 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backK954479 DicomviewHeartlab, Inc. · 1996
- 4 generations backK972229 Imageview Coronary Angiography Display and Review SystemHeartware, Inc. · 1997
- 3 generations backK994210 Inturis SuitePhilips Medical Systems, Inc. · 2000
- 2 generations backK022788 Philips Harmony Release 1Philips Medical Systems North America Co. · 2002 · Recalled
- 1 generation backK061995 XceleraPhilips Medical Systems North America Co. · 2006
- This deviceK103815 Q-StationPhilips Ultrasound, Inc. · 2011
- Descendant · cites it directly · 0 of its ownK131385 Easy-GraftDegradable Solutions AG · 2013
Most influential descendants
Showing 1 of 1 · See all- K131385Easy-GraftDegradable Solutions AG · 2013 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K954479 | Dicomview | Heartlab, Inc. | 1996 | — |
| −4 | K972229 | Imageview Coronary Angiography Display and Review System | Heartware, Inc. | 1997 | — |
| −3 | K994210 | Inturis Suite | Philips Medical Systems, Inc. | 2000 | — |
| −2 | K022788 | Philips Harmony Release 1 | Philips Medical Systems North America Co. | 2002 | 2 |
| −1 | K061995 | Xcelera | Philips Medical Systems North America Co. | 2006 | — |
| 0 (this device) | K103815 | Q-Station | Philips Ultrasound, Inc. | 2011 | — |
| +1 | K131385 | Easy-Graft | Degradable Solutions AG | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 2001 | 1 | 0 |
| 2004 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 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 |
|---|---|---|---|
| * | K061995 | XceleraSummary page 1…uivalent Devices Philips Ultrasound believes that the Q-Station 1.0 software is substantially equivalent to other commercially available products, specifically Xcelera (K06 1995). 3) Device Description Q-Station is workstation software designed for managing, viewing and reporting qualitative and quantita… | 2006 |
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 |
|---|---|---|---|
| K131385 | Easy-Graft | 2013 | 0 |
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 15 years and passes through 5 companies; a new generation was cleared every 2.7 years on median.
- 3 of the 10 ancestors have a recall of any class.
- Of its descendants, K131385 (Degradable Solutions AG, 2013) has gone furthest, with 0 descendants of its own.
- 6 other devices also cite its predicate K061995.
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?
Q-Station software is a software application package. It is designed to manage, view and report image data acquired by Ultrasound systems and cardiac waveformn data from Philips StressVue EGG systems. Q-Station offers support for QLAB plug-ins for analysis, quantification and reporting of data from ultrasound systems.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K103815 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103815: Q-Station.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103815
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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