510(k) · Cleared
Recalled · Class II · 2026MAC VU360 Resting ECG Analysis System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ge Medical Systems Information Technologies, Inc. · DPS Electrocardiograph
Cleared on Sep 18, 2018 as substantially equivalent to K142105 (Mortara Instrument, Inc., 2014) after a 274-day review. Its family tree reaches back 4 generations to 1994. 3 later devices descend from it. It has been recalled 4 times.
- Decided
- Sep 18, 2018
- Review
- 274 days
- Class
- Class II
- Product code
- DPS
- Recalls
- 4
- Predicates
- 1
Its longest line of descent runs back 4 generations to K933143 (1994). 3 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK933143 Model Eli 300 ElectrocardiographMortara Instrument, Inc. · 1994
- 3 generations backK062677 Eli 350 ElectrocardiographMortara Instrument, Inc. · 2006
- 2 generations backK082946 Mortara Eli 350 ElectrocardiographMortara Instrument, Inc. · 2008
- 1 generation backK142105 Eli 380 ElectrocardiographMortara Instrument, Inc. · 2014 · Recalled
- This deviceK173830 MAC VU360 Resting ECG Analysis SystemGe Medical Systems Information Technologies, Inc. · 2018
- Descendant · cites it directly · 2 of its ownK203786 MAC 7 - Resting ECG Analysis SystemGe Medical Systems Information Technologies, Inc. · 2021
- Descendant · 2 generations on · 0 of its ownK251670 MAC 7 Resting ECG Analysis SystemGe Medical Systems Information Technologies, Inc. · 2026
- Descendant · 2 generations on · 0 of its ownK221321 MAC 5 A4/ MAC 5 A5/ MAC 5 Lite Resting ECG Analysis SystemGe Medical Systems Information Technologies, Inc. · 2022 · Recalled
Most influential descendants
Showing 3 of 3 · See all- K203786MAC 7 - Resting ECG Analysis SystemGe Medical Systems Information Technologies, Inc. · 2021 · cites it directly2descendants
- K251670MAC 7 Resting ECG Analysis SystemGe Medical Systems Information Technologies, Inc. · 2026 · 2 generations on0descendants
- K221321MAC 5 A4/ MAC 5 A5/ MAC 5 Lite Resting ECG Analysis SystemGe Medical Systems Information Technologies, Inc. · 2022 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K933143 | Model Eli 300 Electrocardiograph | Mortara Instrument, Inc. | 1994 | — |
| −3 | K062677 | Eli 350 Electrocardiograph | Mortara Instrument, Inc. | 2006 | — |
| −2 | K082946 | Mortara Eli 350 Electrocardiograph | Mortara Instrument, Inc. | 2008 | — |
| −1 | K142105 | Eli 380 Electrocardiograph | Mortara Instrument, Inc. | 2014 | 3 |
| 0 (this device) | K173830 | MAC VU360 Resting ECG Analysis System | Ge Medical Systems Information Technologies, Inc. | 2018 | — |
| +1 | K203786 | MAC 7 - Resting ECG Analysis System | Ge Medical Systems Information Technologies, Inc. | 2021 | — |
| +2 | K251670 | MAC 7 Resting ECG Analysis System | Ge Medical Systems Information Technologies, Inc. | 2026 | — |
| +2 | K221321 | MAC 5 A4/ MAC 5 A5/ MAC 5 Lite Resting ECG Analysis System | Ge Medical Systems Information Technologies, Inc. | 2022 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2026 | 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 DPS? 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 DPS device
- #1 K212112 Cardiologs Holter Platformscore 18.6 · 5 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 |
|---|---|---|---|
| * | K142105 | Eli 380 ElectrocardiographSummary page 4…Receiver Product Codes: DPS, DQK, and DXH Predicate Device(s): ELITM 380 Resting Electrocardiograph (K142105) Reference Device(s): MACTM 5500 HD Resting ECG Analysis System (K073625) 12SLTM (v23… | 2014 |
| † | K073625 | Modification to: Mac 5500 Resting Ecg Analysis System | 2008 |
| † | K141963 | 12SL Ecg Analysis Program | 2015 |
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 |
|---|---|---|---|
| K203786 | MAC 7 - Resting ECG Analysis System | 2021 | 2 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 29, 2026 | Class II | Z-2876-2026 | Software design | Software issue issue with the MAC VU360 v3.0 system. After selecting the order refresh icon, an open preview or review screen might fail to close automatically after 2 minutes of inactivity. As a result, data from a previous patient may… |
| Aug 22, 2025 | Class II | Z-0231-2026 | Device Design | If a user incorrectly places the Acquisition Module into the Acquisition Module Holder, it can result in excessive bending and wear of the Acquisition Trunk Cable. This is visible as a damaged sheath or exposed wires. If a damaged… |
| Oct 27, 2020 | Class II | Z-0543-2021 | Use error | Incorrect patient identification and/or patient demographic errors. |
| Jun 28, 2019 | Class II | Z-2060-2019 | Software design | Two issues: 1) The MAC VU360 system may intermittently display an incorrect patient ID or visit number on the screen after scanning the patient s barcode. This may result in the ECG report being assigned to the incorrect patient. 2) The… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 24 years and passes through 2 companies; a new generation was cleared every 5.7 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K203786 (Ge Medical Systems Information Technologies, Inc., 2021) has gone furthest, with 2 descendants of its own.
How does its category compare?
All DPS devicesDPS Electrocardiograph: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · DPS
6in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DPS
163in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DPS
3in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · DPS
55in 2025
MAUDE reports naming product code DPS, 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 | 11 | 87 | 2 | 9 |
| 2008 | 13 | 31 | 0 | 17 |
| 2009 | 14 | 84 | 1 | 14 |
| 2010 | 11 | 104 | 2 | 21 |
| 2011 | 22 | 154 | 1 | 121 |
| 2012 | 12 | 117 | 0 | 56 |
| 2013 | 10 | 134 | 0 | 15 |
| 2014 | 11 | 253 | 0 | 15 |
| 2015 | 8 | 178 | 0 | 30 |
| 2016 | 11 | 229 | 0 | 12 |
| 2017 | 9 | 177 | 0 | 15 |
| 2018 | 14 | 221 | 0 | 19 |
| 2019 | 3 | 178 | 9 | 27 |
| 2020 | 6 | 224 | 2 | 59 |
| 2021 | 5 | 135 | 1 | 24 |
| 2022 | 6 | 244 | 1 | 59 |
| 2023 | 10 | 236 | 3 | 54 |
| 2024 | 8 | 260 | 4 (1) | 64 |
| 2025 | 6 | 163 | 3 | 55 |
| 2026 | 6 | 258 | 4 | — |
What is it indicated for?
The MAC VU360 Resting ECG Analysis System is a non-invasive prescription device. -The device is indicated for use to acquire, analyze, display and print electrocardiograms. -The device is indicated for use to provide interpretation of the data for consideration by a physician. -The device is indicated for use in a clinical setting, by a physician or by trained personnel who are acting on the orders of a licensed physician. It is not intended as a sole…
Read the full statement (125 words)
The MAC VU360 Resting ECG Analysis System is a non-invasive prescription device.
-The device is indicated for use to acquire, analyze, display and print electrocardiograms.
-The device is indicated for use to provide interpretation of the data for consideration by a physician.
-The device is indicated for use in a clinical setting, by a physician or by trained personnel who are acting on the orders of a licensed physician. It is not intended as a sole means of diagnosis.
-The interpretations of ECG offered by the device are only significant when used in conjunction with a physician over-read as well as consideration of all other relevant patient data.
-The device is indicated for use on adult and pediatric (birth through 21 years of age) populations.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K173830 · printed Nov 6, 2026
Cite this page
510(k) Report. “K173830: MAC VU360 Resting ECG Analysis System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K173830
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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