510(k) · Cleared
Recalled · Class II · 2026CASE V7.0 Cardiac Testing System and CardioSoft V7.0 Cardiac Testing System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ge Medical Systems Information Technologies, Inc. · DQK Computer, Diagnostic, Programmable
Cleared on Dec 13, 2023 as substantially equivalent to K103678 (Ge Medical Systems Information Technologies GmbH, 2011) after a 170-day review. Its family tree reaches back 6 generations to 1991. It has been recalled once.
- Decided
- Dec 13, 2023
- Review
- 170 days
- Class
- Class II
- Product code
- DQK
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 6 generations to K903644 (1991). 9 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backK903644 Series 1500 12-Lead Analysis OptionMarquette Electronics, Inc. · 1991
- 5 generations backK973403 Cardiosmart STMarquette Medical Systems, Inc. · 1998
- 4 generations backK991014 Case 8000 Exercise Testing SystemGeneral Electric Medical Systems Information Techn · 1999
- 3 generations backK023380 T-Wave Altermans (Twa) Algorithm OptionGeneral Electric Medical Systems Information Techn · 2002
- 2 generations backK031561 Cardiosoft/Case Cardiac Testing SystemGe Medical Systems Information Technologies · 2003
- 1 generation backK103678 Case Cardiac Testing System, CS Cardiac Testing SystemGe Medical Systems Information Technologies GmbH · 2011
- This deviceK231870 CASE V7.0 Cardiac Testing System and CardioSoft V7.0 Cardiac Testing…Ge Medical Systems Information Technologies, Inc. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K903644 | Series 1500 12-Lead Analysis Option | Marquette Electronics, Inc. | 1991 | — |
| −5 | K973403 | Cardiosmart ST | Marquette Medical Systems, Inc. | 1998 | — |
| −4 | K991014 | Case 8000 Exercise Testing System | General Electric Medical Systems Information Techn | 1999 | — |
| −3 | K023380 | T-Wave Altermans (Twa) Algorithm Option | General Electric Medical Systems Information Techn | 2002 | — |
| −2 | K031561 | Cardiosoft/Case Cardiac Testing System | Ge Medical Systems Information Technologies | 2003 | — |
| −1 | K103678 | Case Cardiac Testing System, CS Cardiac Testing System | Ge Medical Systems Information Technologies GmbH | 2011 | — |
| 0 (this device) | K231870 | CASE V7.0 Cardiac Testing System and CardioSoft V7.0 Cardiac Testing System | Ge Medical Systems Information Technologies, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 2 | 0 |
| 2000 | 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 26.6 · 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 |
|---|---|---|---|
| * | K103678 | Case Cardiac Testing System, CS Cardiac Testing SystemSummary page 5…ter, diagnostic, programmable Product Code: DQK 21CFR.870.1425 Predicate Device(s): CASE Cardiac Testing System, CS Cardiac Testing System (K103678) Device Description: The CASE V7.0 Cardiac Testing System and the CardioSoft V7.0 Ca… | 2011 |
| † | K080141 | PC Ecg 1200W System | 2008 |
| † | K031194 | Spirosoft | 2003 |
| † | K993921 | NDD Medical Technologies Easyone Spirometer: Frontline Model 2000 and Diagnostic Model… | 2000 |
| † | K090034 | Easy on-PC Spirometer | 2009 |
| † | K012647 | Tonoport V | 2001 |
| † | K170966 | Tonoport VI | 2017 |
| † | K173830 | MAC VU360 Resting ECG Analysis System | 2018 |
| † | K091594 | Heart-Exercise | 2009 |
| † | K060833 | 12SL Ecg Analysis Program | 2006 |
| † | K141963 | 12SL Ecg Analysis Program | 2015 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 24, 2026 | Class II | Z-2279-2026 | Process control | Electrical sparking may occur at the printer head. If the Electrostatic Discharge (ESD) printer brush becomes dislodged, electrical sparking at the printer head can result in charring or discoloration of thermal printer paper. Ignition of… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 32 years and passes through 6 companies; a new generation was cleared every 6.2 years on median.
- None of the 9 ancestors has a recall.
How does its category compare?
All DQK devicesDQK Computer, Diagnostic, Programmable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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?
CASE V7.0 Cardiac Testing System and CardioSoft V7.0 Cardiac Testing System are intended to be used by trained operators under direct supervision of a licensed health care practitioner on adult and pediatric patients. The CASE V7.0 Cardiac Testing System and CardioSoft V7.0 Cardiac Testing System are designed to acquire, process, record, archive, analyze and output (12 and 15 lead) ECG data during a period of physiologic stress or during a resting ECG…
Read the full statement (469 words)
CASE V7.0 Cardiac Testing System and CardioSoft V7.0 Cardiac Testing System are intended to be used by trained operators under direct supervision of a licensed health care practitioner on adult and pediatric patients.
The CASE V7.0 Cardiac Testing System and CardioSoft V7.0 Cardiac Testing System are designed to acquire, process, record, archive, analyze and output (12 and 15 lead) ECG data during a period of physiologic stress or during a resting ECG test, acquire data from ancillary devices (such as Spirometry and Ambulatory Blood Pressure), provide median morphology recordings and record ECG in real-time with and without arrhythmia detection.
The arrhythmia detection portion of CASE V7.0 Cardiac Testing System and CardioSoft V7.0 Cardiac Testing System are provided to the user for the convenience of automatic detection of arrhythmias but do not provide alarms.
CASE V7.0 Cardiac Testing System and CardioSoft V7.0 Cardiac Testing System provide the control of external devices (typically a treadmill or bicycle ergometer) and communicate with centralized electronic/digital storage system via data networks.
CASE V7.0 Cardiac Testing System and CardioSoft V7.0 Cardiac Testing System provide a user selectable option for printouts of prognostic scores on selected reports. Vector loops are also available.
CASE V7.0 Cardiac Testing System and CardioSoft V7.0 Cardiac Testing System can be configured in a network environment for multiple CASE and CardioSoft stations allowing the user to create a central database of patient demographics and collected patient physiological data.
CASE V7.0 Cardiac Testing System and CardioSoft V7.0 Cardiac Testing System are intended to be used primarily in the hospital but can also be used in clinics, physician offices, outreach centers or wherever exercise, stress testing, ECG, Spirometry or ambulatory blood pressure testing is performed.
CASE V7.0 Cardiac Testing System and CardioSoft V7.0 Cardiac Testing System offer no diagnostic opinion to the user. Instead, it provides interpretive statements of morphology, rhythm, and conduction for which the physician renders his/her own medical opinion.
CASE V7.0 Cardiac Testing System and CardioSoft V7.0 Cardiac Testing System are not intended to be used as a transport device or for home use.
CASE V7.0 Cardiac Testing System and CardioSoft V7.0 Cardiac Testing System are not intended for use as a vital signs physiological monitor.
CASE V7.0 Cardiac Testing System and CardioSoft V7.0 Cardiac Testing System are not intended for intracardiac use.
CASE V7.0 Cardiac Testing System and CardioSoft V7.0 Cardiac Testing System are not intended for use as an emergency device.
CASE V7.0 Cardiac Testing System and CardioSoft V7.0 Cardiac Testing System will not cause abnormal operation of a patient's cardiac pacemaker or other electronic stimulators.
CASE V7.0 Cardiac Testing System and CardioSoft V7.0 Cardiac Testing System are not intended for use with high frequency surgical units. Disconnect the patient from CASE V7.0 Cardiac Testing System and CardioSoft V7.0 Cardiac Testing System before using the high frequency surgical unit.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K231870 · printed Nov 5, 2026
Cite this page
510(k) Report. “K231870: CASE V7.0 Cardiac Testing System and CardioSoft V7.0 Cardiac Testing System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K231870
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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