510(k) · Cleared
ClearedAcQMap High Resolution Imaging and Mapping System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Acutus Medical, Inc. · DQK Computer, Diagnostic, Programmable
Cleared on Oct 16, 2017 as substantially equivalent to K130594 (St Jude Medical, 2013) and 1 other predicate after a 200-day review. Its family tree reaches back 6 generations to 1992. 11 later devices descend from it.
- Decided
- Oct 16, 2017
- Review
- 200 days
- Class
- Class II
- Product code
- DQK
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K921750 (1992). 12 ancestors in all. 11 later devices descend from it, 2 citing it directly.
- Root · 6 generations backK921750 Cvis Insight Iii SystemCardiovascular Imaging Systems, Inc. · 1992
- 5 generations backK980851 Galaxy Intravascular Ultrasound System, Model I5028Boston Scientific Corp · 1998
- 4 generations backK051679 Ilab Ultrasound Imaging SystemBoston Scientific Corp · 2005 · Recalled
- 3 generations backK072517 Ilab Ultrasound Imaging System, Version 1.3Boston Scientific Corp · 2007 · Recalled
- 2 generations backK123535 Ilab Ultrasound Imaging SystemBoston Scientific Corp · 2013
- 1 generation backK130243 Ilab Ultrasound Imaging SystemBoston Scientific Corp · 2013
- This deviceK170948 AcQMap High Resolution Imaging and Mapping SystemAcutus Medical, Inc. · 2017
- Descendant · cites it directly · 9 of its ownK190131 AcQMap High Resolution Imaging and Mapping SystemAcutus Medical, Inc. · 2019
- Descendant · 2 generations on · 8 of its ownK191392 AcQMap High Resolution Imaging and Mapping SystemAcutus Medical, Inc. · 2019
- Descendant · 3 generations on · 7 of its ownK193013 AcQMap High Resolution Imaging and Mapping SystemAcutus Medical, Inc. · 2020
- Descendant · 4 generations on · 5 of its ownK201015 AcQMap High Resolution Imaging and Mapping SystemAcutus Medical, Inc. · 2020
- Descendant · 5 generations on · 4 of its ownK212345 AcQMap High Resolution Imaging and Mapping SystemAcutus Medical, Inc. · 2021
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K190131AcQMap High Resolution Imaging and Mapping SystemAcutus Medical, Inc. · 2019 · cites it directly9descendants
- K191392AcQMap High Resolution Imaging and Mapping SystemAcutus Medical, Inc. · 2019 · 2 generations on8descendants
- K193013AcQMap High Resolution Imaging and Mapping SystemAcutus Medical, Inc. · 2020 · 3 generations on7descendants
- K201015AcQMap High Resolution Imaging and Mapping SystemAcutus Medical, Inc. · 2020 · 4 generations on5descendants
- K212345AcQMap High Resolution Imaging and Mapping SystemAcutus Medical, Inc. · 2021 · 5 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K921750 | Cvis Insight Iii System | Cardiovascular Imaging Systems, Inc. | 1992 | — |
| −5 | K980851 | Galaxy Intravascular Ultrasound System, Model I5028 | Boston Scientific Corp | 1998 | — |
| −4 | K051679 | Ilab Ultrasound Imaging System | Boston Scientific Corp | 2005 | 2 |
| −3 | K072517 | Ilab Ultrasound Imaging System, Version 1.3 | Boston Scientific Corp | 2007 | 1 |
| −2 | K123535 | Ilab Ultrasound Imaging System | Boston Scientific Corp | 2013 | — |
| −1 | K130243 | Ilab Ultrasound Imaging System | Boston Scientific Corp | 2013 | — |
| 0 (this device) | K170948 | AcQMap High Resolution Imaging and Mapping System | Acutus Medical, Inc. | 2017 | — |
| +1 | K190131 | AcQMap High Resolution Imaging and Mapping System | Acutus Medical, Inc. | 2019 | — |
| +2 | K191392 | AcQMap High Resolution Imaging and Mapping System | Acutus Medical, Inc. | 2019 | — |
| +3 | K193013 | AcQMap High Resolution Imaging and Mapping System | Acutus Medical, Inc. | 2020 | — |
| +4 | K201015 | AcQMap High Resolution Imaging and Mapping System | Acutus Medical, Inc. | 2020 | — |
| +5 | K212345 | AcQMap High Resolution Imaging and Mapping System | Acutus Medical, Inc. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 2 | 0 |
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 3 | 0 |
| 2020 | 2 | 0 |
| 2021 | 2 | 0 |
| 2022 | 2 | 0 |
| 2023 | 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 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? (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 |
|---|---|---|---|
| * | K130594 | Ensite Velocity SystemSummary page 5…FR § 892.1560 Product Code: DQK, IYO, ITX A5-3 K170948 510(k) SUMMARY PREDICATE DEVICE(S) [807.92(a)(3)] e EnSite Velocity™ Cardiac Mapping System (K130594); and e iLab™ Ultrasound Imaging System (K130243) DEVICE DESCRIPTION [807.92(a)(4)] The AcQMap System operates outside of the s… | 2013 |
| * | K130243 | Ilab Ultrasound Imaging SystemSummary page 5…K170948 510(k) SUMMARY PREDICATE DEVICE(S) [807.92(a)(3)] e EnSite Velocity™ Cardiac Mapping System (K130594); and e iLab™ Ultrasound Imaging System (K130243) DEVICE DESCRIPTION [807.92(a)(4)] The AcQMap System operates outside of the sterile field and consists of the AcQMap Console,… | 2013 |
What descends from it? (11)
See all 112 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)
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 25 years and passes through 3 companies; a new generation was cleared every 5.3 years on median.
- 2 of the 12 ancestors have a recall of any class.
- Of its descendants, K190131 (Acutus Medical, Inc., 2019) has gone furthest, with 9 descendants of its own.
- 1 other device also cites its predicate K130594.
How does its category compare?
All DQK devicesDQK Computer, Diagnostic, Programmable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
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?
The AcQMap® High Resolution Imaging and Mapping System is intended for use in patients for whom electrophysiology procedures have been prescribed. When used with the AcQMap Catheters, the AcQMap System is intended to be used to reconstruct the selected chamber from ultrasound data for purposes of visualizing the chamber anatomy and displaying electrical impulses as either dipole density-based or voltage-based maps of complex arrhythmias that may be…
Read the full statement (103 words)
The AcQMap® High Resolution Imaging and Mapping System is intended for use in patients for whom electrophysiology procedures have been prescribed.
When used with the AcQMap Catheters, the AcQMap System is intended to be used to reconstruct the selected chamber from ultrasound data for purposes of visualizing the chamber anatomy and displaying electrical impulses as either dipole density-based or voltage-based maps of complex arrhythmias that may be difficult to identify using conventional mapping systems alone.
AND
When used with the specified Patient Electrodes, the AcQMap System is intended to display the position of AcQMap Catheters and conventional electrophysiology (EP) catheters in the heart.
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/K170948 · printed Nov 5, 2026
Cite this page
510(k) Report. “K170948: AcQMap High Resolution Imaging and Mapping System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K170948
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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