510(k) · Cleared
ClearedMckesson Cardiology Ecg Mobile
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mckesson Israel, Ltd. · DQK Computer, Diagnostic, Programmable
Cleared on Apr 18, 2014 as substantially equivalent to K113515 (Mckesson Israel, Ltd., 2012) and 1 other predicate after a 151-day review. Its family tree reaches back 7 generations to 1984. 6 later devices descend from it.
- Decided
- Apr 18, 2014
- Review
- 151 days
- Class
- Class II
- Product code
- DQK
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K842308 (1984). 18 ancestors in all. 6 later devices descend from it, 2 citing it directly.
- Root · 7 generations backK842308 12SSL-SCMarquette Electronics, Inc. · 1984
- 6 generations backK980495 Muse Cardiovascular Information SystemMarquette Medical Systems, Inc. · 1998
- 5 generations backK992637 Muse Cardiovascular Information SystemGeneral Electric Medical Systems Information Techn · 1999 · Recalled
- 4 generations backK031970 Infinity MegacareSiemens Medical Solutions USA, Inc. · 2003
- 3 generations backK050858 Ascentia Heartstation Ecg Management SystemHeartlab, Inc. · 2005 · Recalled
- 2 generations backK061905 Horizon Cardiology Ecg-Mckesson's Ecg Management System, Model 1.0Medcon, Ltd. · 2006
- 1 generation backK113515 Horizon Cardiology Ecg ManagementMckesson Israel, Ltd. · 2012 · Recalled
- This deviceK133534 Mckesson Cardiology Ecg MobileMckesson Israel, Ltd. · 2014
- Descendant · cites it directly · 4 of its ownK151774 CARESTREAM Vue MotionCarestream Health, Inc. · 2015 · Recalled
- Descendant · 2 generations on · 3 of its ownK170434 Enterprise Imaging XERO Viewer 8.1Agfa Healthcare N.V. · 2017 · Recalled
- Descendant · 3 generations on · 1 of its ownK200822 BraidBraid.Health · 2020
- Descendant · 3 generations on · 0 of its ownK252199 AGFA HealthCare Enterprise ImagingAgfa Healthcare N.V. · 2025
- Descendant · 4 generations on · 0 of its ownK231385 Rology Teleradiology Platform (v.1.22.1103)Rology, Inc. · 2023
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K151774CARESTREAM Vue MotionCarestream Health, Inc. · 2015 · cites it directly4descendants
- K170434Enterprise Imaging XERO Viewer 8.1Agfa Healthcare N.V. · 2017 · 2 generations on3descendants
- K200822BraidBraid.Health · 2020 · 3 generations on1descendant
- K252199AGFA HealthCare Enterprise ImagingAgfa Healthcare N.V. · 2025 · 3 generations on0descendants
- K231385Rology Teleradiology Platform (v.1.22.1103)Rology, Inc. · 2023 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K842308 | 12SSL-SC | Marquette Electronics, Inc. | 1984 | — |
| −6 | K980495 | Muse Cardiovascular Information System | Marquette Medical Systems, Inc. | 1998 | — |
| −5 | K992637 | Muse Cardiovascular Information System | General Electric Medical Systems Information Techn | 1999 | 1 |
| −4 | K031970 | Infinity Megacare | Siemens Medical Solutions USA, Inc. | 2003 | — |
| −3 | K050858 | Ascentia Heartstation Ecg Management System | Heartlab, Inc. | 2005 | 1 |
| −2 | K061905 | Horizon Cardiology Ecg-Mckesson's Ecg Management System, Model 1.0 | Medcon, Ltd. | 2006 | — |
| −1 | K113515 | Horizon Cardiology Ecg Management | Mckesson Israel, Ltd. | 2012 | 2 |
| 0 (this device) | K133534 | Mckesson Cardiology Ecg Mobile | Mckesson Israel, Ltd. | 2014 | — |
| +1 | K151774 | CARESTREAM Vue Motion | Carestream Health, Inc. | 2015 | 1 |
| +2 | K170434 | Enterprise Imaging XERO Viewer 8.1 | Agfa Healthcare N.V. | 2017 | 2 |
| +3 | K200822 | Braid | Braid.Health | 2020 | — |
| +3 | K252199 | AGFA HealthCare Enterprise Imaging | Agfa Healthcare N.V. | 2025 | — |
| +4 | K231385 | Rology Teleradiology Platform (v.1.22.1103) | Rology, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 2003 | 2 | 0 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 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? (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 |
|---|---|---|---|
| * | K113515 | Horizon Cardiology Ecg ManagementSummary page 1…computer Classification Regulation: 21 CFR § 870.1425 Product code: DQK Device Class: Class Il Predicate Device: McKesson Israel Ltd., Horizon Cardiology ECG Management (K113515), AirStrip Technologies, LP, AirStrip Remote Patient Monitoring (RPM) Remote Data Viewing (K122133) Intended Use / Indications… | 2012 |
| * | K122133 | Airstrip Remote Patient Monitoring (RPM) Remote Data ViewingSummary page 1…cate Device: McKesson Israel Ltd., Horizon Cardiology ECG Management (K113515), AirStrip Technologies, LP, AirStrip Remote Patient Monitoring (RPM) Remote Data Viewing (K122133) Intended Use / Indications for Use McKesson Cardiology ECG Mobile is a software application used for accessing and displaying… | 2012 |
What descends from it? (6)
2 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 30 years and passes through 7 companies; a new generation was cleared every 2.1 years on median.
- 3 of the 18 ancestors have a recall of any class.
- Of its descendants, K151774 (Carestream Health, Inc., 2015) has gone furthest, with 4 descendants of its own.
How does its category compare?
All DQK devicesDQK Computer, Diagnostic, Programmable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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?
McKesson Cardiology ECG Mobile is a software application used for accessing and displaying ECG data and related patient information previously stored, analyzed or retrieved by the Horizon Cardiology ECG Management device. The McKesson Cardioclogy ECG Mobile software application is intended to be used from a mobile device to perform the following: View ECG test results, such as waveforms, synopsis measurements and diagnosis statements, as well as other…
Read the full statement (204 words)
McKesson Cardiology ECG Mobile is a software application used for accessing and displaying ECG data and related patient information previously stored, analyzed or retrieved by the Horizon Cardiology ECG Management device. The McKesson Cardioclogy ECG Mobile software application is intended to be used from a mobile device to perform the following:
View ECG test results, such as waveforms, synopsis measurements and diagnosis statements, as well as other relevant current or historical patient information originally stored, analyzed or retrieved by the Horizon Cardiology ECG Management device.
View the ECG lead traces using different display settings.
Compare the results of current ECG tests with any previous ECG test results stored on the Horizon Cardiology ECG Management device.
Perform ECG-related measurements and edit synopsis measurement values stored on the Horizon Cardiology ECG Management device.
Enter new diagnosis statements and/or modify diagnosis records stored on the Horizon Cardiology ECG Management device.
Confirm ECG procedures and resuits.
Communicate information with the Horizon Cardiology ECG Management device such as login credentials and user settings.
The McKesson Cardiology ECG Mobile application is intended to be used under the direct supervision of a licensed healthcare practitioner and by trained operators.
The McKesson Cardiology ECG Mobile application is not intended for real-time monitoring.
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/K133534 · printed Nov 5, 2026
Cite this page
510(k) Report. “K133534: Mckesson Cardiology Ecg Mobile.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K133534
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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