| Device Type ID | 5329 |
| Device Name | System, Imaging, Pulsed Echo, Ultrasonic |
| Regulation Description | Ultrasonic Pulsed Echo Imaging System. |
| Regulation Medical Specialty | Radiology |
| Review Panel | Radiology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR) |
| Submission Type | 510(k) |
| CFR Regulation Number | 892.1560 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | IYO |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Program |
| Device Type ID | 5329 |
| Device | System, Imaging, Pulsed Echo, Ultrasonic |
| Product Code | IYO |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Ultrasonic Pulsed Echo Imaging System. |
| CFR Regulation Number | 892.1560 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
ACCUTOME, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ADVANCED INSTRUMENTATIONS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ANALOGIC CORP. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
ANALOGIC CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
ARCSCAN, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
B-K MEDICAL APS | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
BOSTON SCIENTIFIC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
BOSTON SCIENTIFIC CORP. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
C.R. BARD, INC. | ||
SUBSTANTIALLY EQUIVALENT | 4 | |
CLEAR GUIDE MEDICAL | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
CONTEC MEDICAL SYSTEMS CO., LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
DELPHINUS MEDICAL TECHNOLOGIES, INC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
DGH TECHNOLOGY, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ECHONOUS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ECHOSENS | ||
SUBSTANTIALLY EQUIVALENT | 6 | |
EDAN INSTRUMENTS INC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
EDAN INSTRUMENTS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
HALO MEDICAL TECHNOLOGIES, LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
KONICA MINOLTA, INC. | ||
SUBSTANTIALLY EQUIVALENT | 4 | |
LIGHTMED USA, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MCUBE TECHNOLOGY CO., LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
QISDA CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
QT ULTRASOUND LLC | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
QUANTEL MEDICAL | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
RIVANNA MEDICAL | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
SIEMENS | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
SIEMENS CAPITAL | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SIEMENS MEDICAL SOLUTIONS INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SONOMED, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
TELEMED | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
THE PROMETHEUS GROUP | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
VERATHON INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
VOLCANO CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 8 | |
WINPROBE CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Retraction Problem | 386 |
Motor Drive Unit | 42 |
System | 35 |
Incorrect Measurement | 35 |
Data Problem | 30 |
Device Operational Issue | 20 |
Adverse Event Without Identified Device Or Use Problem | 17 |
Thermal Decomposition Of Device | 13 |
Device Displays Incorrect Message | 10 |
Inaccurate Synchronization | 10 |
Loss Of Data | 6 |
False Reading From Device Non-Compliance | 5 |
Erratic Or Intermittent Display | 5 |
Incorrect, Inadequate Or Imprecise Result Or Readings | 5 |
Split | 4 |
Calibration Problem | 4 |
Output Problem | 4 |
Failure To Power Up | 4 |
Fire | 4 |
Circuit Failure | 4 |
Electrical /Electronic Property Problem | 4 |
Use Of Device Problem | 4 |
Appropriate Term/Code Not Available | 3 |
Device Operates Differently Than Expected | 3 |
Material Integrity Problem | 3 |
Material Separation | 3 |
Computer Software Problem | 3 |
Break | 2 |
Charred | 2 |
Failure To Align | 2 |
Insufficient Information | 2 |
Electrical Shorting | 2 |
Improper Or Incorrect Procedure Or Method | 2 |
Smoking | 2 |
No Display / Image | 2 |
Endoscope | 1 |
Signal Artifact | 1 |
Loss Of Or Failure To Bond | 1 |
Component Missing | 1 |
Maintenance Does Not Comply To Manufacturers Recommendations | 1 |
Physical Property Issue | 1 |
Catheter | 1 |
Connection Problem | 1 |
Explosion | 1 |
Electro-Static Discharge | 1 |
Solder Joint Fracture | 1 |
Contamination During Use | 1 |
Decoupling | 1 |
Compatibility Problem | 1 |
Measurement System Incompatibility | 1 |
Operating System Becomes Nonfunctional | 1 |
Fracture | 1 |
Incorrect Software Programming Calculations | 1 |
Sparking | 1 |
Communication Or Transmission Problem | 1 |
Cable | 1 |
Imager | 1 |
Device Contamination With Chemical Or Other Material | 1 |
Device Issue | 1 |
Application Program Problem | 1 |
Environmental Compatibility Problem | 1 |
Positioning Failure | 1 |
Device Emits Odor | 1 |
Missing Value Reason | 1 |
Probe | 1 |
Fluid Leak | 1 |
Microbial Contamination Of Device | 1 |
Incorrect Or Inadequate Test Results | 1 |
Temperature Problem | 1 |
Disconnection | 1 |
Loose Or Intermittent Connection | 1 |
Difficult To Advance | 1 |
| Total Device Problems | 719 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | ECOLAB INC | III | Jul-13-2018 |
| 2 | GE Medical Systems Ultrasound & Primary Care Diagnostics, LL | II | Sep-06-2018 |
| 3 | Parker Laboratories, Inc. | II | May-09-2018 |
| 4 | Parker Laboratories, Inc. | II | Oct-29-2014 |
| 5 | Siemens Medical Solutions USA, Inc. | II | May-05-2015 |
| 6 | Siemens Medical Solutions USA, Inc. | II | Feb-07-2015 |
| 7 | Soma Access Systems LLC | II | Dec-16-2014 |
| 8 | Verathon, Inc. | II | Mar-10-2016 |
| 9 | Volcano Corp | II | Jul-08-2015 |
| 10 | Volcano Corporation | II | May-17-2018 |
| 11 | Volcano Corporation | II | Jul-20-2015 |