510(k) · Cleared
ClearedQIVA
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pie Medical Imaging BV · DQK Computer, Diagnostic, Programmable
Cleared on Oct 1, 2002 as substantially equivalent to K011582 (Medis Medical Imaging Systems BV, 2001) after a 145-day review. Its family tree reaches back 4 generations to 1995. 3 later devices descend from it.
- Decided
- Oct 1, 2002
- Review
- 145 days
- Class
- Class II
- Product code
- DQK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K941322 (1995). 3 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK941322 Echo-ScanTomographic Tech · 1995
- 3 generations backK963807 Tomtec Echo-ScanTomtec Imaging Systems, Inc. · 1996
- 2 generations backK993394 Echo Scan, Easy ScanTomtec Imaging Systems GmbH · 1999
- 1 generation backK011582 Qcu Analytical Software PackageMedis Medical Imaging Systems BV · 2001
- This deviceK021495 QIVAPie Medical Imaging BV · 2002
- Descendant · cites it directly · 2 of its ownK092842 EchoplaqueIndec Systems, Inc. · 2010
- Descendant · 2 generations on · 1 of its ownK123970 Caas IntravascularPie Medical Imaging BV · 2013
- Descendant · 3 generations on · 0 of its ownK210931 Libby IAAA v1.0Dyad Medical, Inc. · 2021
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 |
|---|---|---|---|---|---|
| −4 | K941322 | Echo-Scan | Tomographic Tech | 1995 | — |
| −3 | K963807 | Tomtec Echo-Scan | Tomtec Imaging Systems, Inc. | 1996 | — |
| −2 | K993394 | Echo Scan, Easy Scan | Tomtec Imaging Systems GmbH | 1999 | — |
| −1 | K011582 | Qcu Analytical Software Package | Medis Medical Imaging Systems BV | 2001 | — |
| 0 (this device) | K021495 | QIVA | Pie Medical Imaging BV | 2002 | — |
| +1 | K092842 | Echoplaque | Indec Systems, Inc. | 2010 | — |
| +2 | K123970 | Caas Intravascular | Pie Medical Imaging BV | 2013 | — |
| +3 | K210931 | Libby IAAA v1.0 | Dyad Medical, Inc. | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2013 | 1 | 0 |
| 2021 | 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 DQK? 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 DQK device
- #1 K213682 HemoSphere Advanced Monitor, HemoSphere…score 26.7 · 28 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 |
|---|---|---|---|
| * | K011582 | Qcu Analytical Software Package | 2001 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K092842 | Echoplaque | 2010 | 2 |
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 7 years and passes through 5 companies; a new generation was cleared every 1.7 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K092842 (Indec Systems, Inc., 2010) has gone furthest, with 2 descendants of its own.
- 3 other devices also cite its predicate K011582.
How does its category compare?
All DQK devicesDQK Computer, Diagnostic, Programmable: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DQK
23so far in 2026, the most since 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · DQK
95in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DQK
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DQK
433in 2025
MAUDE reports naming product code DQK, 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 | 13 | 83 | 4 | 18 |
| 2008 | 4 | 70 | 1 | 34 |
| 2009 | 12 | 93 | 2 | 40 |
| 2010 | 9 | 64 | 3 | 49 |
| 2011 | 12 | 69 | 2 | 55 |
| 2012 | 7 | 74 | 3 | 129 |
| 2013 | 13 | 68 | 1 | 180 |
| 2014 | 9 | 90 | 4 | 115 |
| 2015 | 7 | 125 | 2 | 131 |
| 2016 | 15 | 190 | 0 | 340 |
| 2017 | 7 | 146 | 2 | 252 |
| 2018 | 14 | 150 | 6 | 261 |
| 2019 | 15 | 113 | 1 | 218 |
| 2020 | 16 | 123 | 1 | 215 |
| 2021 | 16 | 132 | 1 | 351 |
| 2022 | 19 | 136 | 2 | 319 |
| 2023 | 21 | 133 | 2 | 340 |
| 2024 | 13 | 100 | 24 | 557 |
| 2025 | 22 | 95 | 1 | 433 |
| 2026 | 23 | 151 | 2 | — |
What is it indicated for?
1. Digitization of VCR recordings of ICUS (Intra Coronary Ultra Sound) or IVUS (Intra Vascular Ultra Sound) examinations of patients to the (IVUS) DICOM 3 format
2. Quantitative analysis of artery and stent dimensions.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K021495 · printed Nov 5, 2026
Cite this page
510(k) Report. “K021495: QIVA.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K021495
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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