| Device Type ID | 735 |
| Device Name | Computer, Diagnostic, Programmable |
| Regulation Description | Programmable Diagnostic Computer. |
| Regulation Medical Specialty | Cardiovascular |
| Review Panel | Cardiovascular |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Cardiovascular Devices (DCD) Cardiac Diagnostics Devices Branch (CDDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 870.1425 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | DQK |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Expansion Pilot Program |
| Device Type ID | 735 |
| Device | Computer, Diagnostic, Programmable |
| Product Code | DQK |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Programmable Diagnostic Computer. |
| CFR Regulation Number | 870.1425 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
ABBOTT | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
ABBOTT LABORATORIES | ||
SUBSTANTIALLY EQUIVALENT | 12 | |
ADAMS MEDITECH LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ALIVECOR, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
BIOSENSE | ||
SUBSTANTIALLY EQUIVALENT | 6 | |
BIOSENSE WEBSTER, INC. | ||
SUBSTANTIALLY EQUIVALENT | 6 | |
BOSTON SCIENTIFIC CORP. | ||
SUBSTANTIALLY EQUIVALENT | 4 | |
BOSTON SCIENTIFIC CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 4 | |
CARDIOINSIGHT TECHNOLOGIES, INC | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
CARDIOTEK, B.V. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
CAREFUSION | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
EDAN INSTRUMENTS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
EDWARDS LIFESCIENCES | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
EDWARDS LIFESCIENCES, LLC | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
GETEMED | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
GETEMED MEDIZIN- UND INFORMATIONSTECHNIK AG | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
IRHYTHM TECHNOLOGIES, INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
MCKESSON MEDICAL IMAGING COMPANY | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MEDTRONIC INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MEDTRONIC, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MERGE HEALTHCARE | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MORTARA | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MORTARA INSTRUMENT, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
PHILIPS MEDICAL SYSTEMS INTERNATIONAL BV | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SIEMENS | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SPACELABS HEALTHCARE | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SPACELABS HEALTHCARE LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ST. JUDE MEDICAL, INC. | ||
SUBSTANTIALLY EQUIVALENT | 8 | |
| Device Problems | |
|---|---|
Application Interface Becomes Non-Functional Or Program Exits Abnormally | 112 |
Communication Or Transmission Problem | 102 |
Device Issue | 90 |
Device Operational Issue | 88 |
Failure To Transmit Record | 73 |
Data Problem | 65 |
Computer Software Problem | 38 |
Application Program Problem | 37 |
Device Operates Differently Than Expected | 34 |
Retraction Problem | 32 |
Image Orientation Incorrect | 32 |
No Display / Image | 30 |
EKG/ECG Monitor | 27 |
Blocked Connection | 25 |
Device Displays Incorrect Message | 25 |
Adverse Event Without Identified Device Or Use Problem | 21 |
Failure To Power Up | 20 |
Incorrect Measurement | 19 |
Cable | 17 |
Power Problem | 16 |
Erratic Or Intermittent Display | 16 |
Insufficient Information | 15 |
Improper Device Output | 15 |
Signal Artifact | 15 |
Connection Problem | 14 |
Failure To Cycle | 14 |
Noise, Audible | 13 |
Overheating Of Device | 13 |
Display Or Visual Feedback Problem | 13 |
Pacing Problem | 13 |
Output Problem | 11 |
Patient Data Problem | 11 |
Loss Of Data | 11 |
Smoking | 9 |
Failure Of Device To Self-Test | 9 |
Use Of Device Problem | 7 |
Application Program Freezes, Becomes Nonfunctional | 7 |
Battery Problem | 7 |
Difficult To Remove | 7 |
Device Component Or Accessory | 6 |
Battery | 6 |
Monitor | 6 |
Image Display Error / Artifact | 6 |
Computer Hardware | 6 |
Incorrect, Inadequate Or Imprecise Result Or Readings | 5 |
Disconnection | 5 |
Device Alarm System | 5 |
Intermittent Communication Failure | 5 |
No Apparent Adverse Event | 5 |
Appropriate Term/Code Not Available | 5 |
No Pacing | 4 |
Electrical /Electronic Property Problem | 4 |
Sparking | 4 |
Failure To Zero | 4 |
Fuse | 4 |
Computer Operating System Problem | 4 |
Device Emits Odor | 4 |
Application Network Problem | 3 |
Interface | 3 |
Connector | 3 |
Loose Or Intermittent Connection | 3 |
Break | 3 |
Bent | 3 |
Inappropriate Shock | 3 |
Failure To Read Input Signal | 3 |
Device Stops Intermittently | 3 |
EKG/ECG Subassembly (Only Use When Part Of Another Device) | 3 |
Decoupling | 2 |
Electronic Property Issue | 2 |
Application Program Version Or Upgrade Problem | 2 |
Inaccurate Synchronization | 2 |
No Device Output | 2 |
Temperature Problem | 2 |
Calibration Problem | 2 |
Missing Value Reason | 2 |
Malposition Of Device | 2 |
Impedance Problem | 2 |
Connector Pin | 2 |
Use Of Incorrect Control Settings | 2 |
Keyboard | 1 |
Recorder (Tape, Stripchart, Etc.) | 1 |
Generator | 1 |
Radio Signal Problem | 1 |
Human Factors Issue | 1 |
Installation-Related Problem | 1 |
Operating System Version Or Upgrade Problem | 1 |
Unexpected Shutdown | 1 |
Device Contamination With Chemical Or Other Material | 1 |
Failure To Obtain Sample | 1 |
Arcing | 1 |
Detachment Of Device Component | 1 |
Power Cord | 1 |
Transducer | 1 |
Lead | 1 |
Pacing Asynchronously | 1 |
Failure To Select Signal | 1 |
Moisture Damage | 1 |
User Interface | 1 |
Detachment Of Device Or Device Component | 1 |
No Fail-Safe Mechanism | 1 |
| Total Device Problems | 1286 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Biosense Webster, Inc. | II | Sep-09-2016 |
| 2 | Biosense Webster, Inc. | II | Oct-01-2015 |
| 3 | Biosense Webster, Inc. | II | Feb-20-2014 |
| 4 | CardioTek BV | II | Jun-30-2017 |
| 5 | Edwards Lifesciences, LLC | II | Jan-16-2018 |
| 6 | Fujifilm Medical Systems U.S.A., Inc. | II | May-14-2015 |
| 7 | Fujifilm Medical Systems U.S.A., Inc. | II | May-14-2015 |
| 8 | GE Healthcare Finland Oy | II | Oct-10-2018 |
| 9 | GE Healthcare Finland Oy | II | Jul-02-2018 |
| 10 | GE Medical Systems Information Technologies, Inc. | II | Jan-25-2018 |
| 11 | Hitachi Healthcare Americas Corp Informatics Division | II | Sep-06-2018 |
| 12 | Invivo Corporation | II | Nov-14-2018 |
| 13 | McKesson Israel Ltd. | II | Aug-31-2018 |
| 14 | McKesson Israel Ltd. | II | Jan-05-2015 |
| 15 | Merge Healthcare, Inc. | II | Jan-14-2018 |
| 16 | Merge Healthcare, Inc. | II | Jul-10-2017 |
| 17 | Merge Healthcare, Inc. | II | Jun-29-2017 |
| 18 | Merge Healthcare, Inc. | II | May-02-2017 |
| 19 | Merge Healthcare, Inc. | II | Apr-11-2017 |
| 20 | Merge Healthcare, Inc. | II | Mar-14-2017 |
| 21 | Merge Healthcare, Inc. | II | Feb-15-2017 |
| 22 | Merge Healthcare, Inc. | II | Jan-24-2017 |
| 23 | Merge Healthcare, Inc. | II | Nov-28-2016 |
| 24 | Merge Healthcare, Inc. | II | Aug-04-2016 |
| 25 | Merge Healthcare, Inc. | II | Dec-28-2015 |
| 26 | Merge Healthcare, Inc. | II | Aug-06-2015 |
| 27 | Merge Healthcare, Inc. | II | Oct-28-2014 |
| 28 | Philips Electronics North America Corporation | II | Dec-14-2018 |
| 29 | Philips Medical Systems, Inc. | II | Aug-21-2014 |
| 30 | Siemens Medical Solutions USA, Inc | II | Feb-23-2019 |
| 31 | Siemens Medical Solutions USA, Inc | II | Jul-06-2017 |
| 32 | Siemens Medical Solutions USA, Inc | II | May-24-2017 |
| 33 | Spacelabs Healthcare, Llc | II | Mar-25-2014 |