| Device Type ID | 5276 |
| Device Name | Transducer, Ultrasonic, Diagnostic |
| Regulation Description | Diagnostic Ultrasonic Transducer. |
| 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 | 892.1570 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | ITX |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Program |
|
| Device Type ID | 5276 |
| Device | Transducer, Ultrasonic, Diagnostic |
| Product Code | ITX |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Diagnostic Ultrasonic Transducer. |
| CFR Regulation Number | 892.1570 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
BIOBOT SURGICAL PTE LTD | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
BOSTON SCIENTIFIC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
BOSTON SCIENTIFIC CORP. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
C.R. BARD, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
CIVCO | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
CIVCO MEDICAL INSTRUMENTS CO., INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
COOK, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
CORBIN CLINICAL RESOURCES, LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
GENERAL ELECTRIC CO. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
HITACHI ALOKA MEDICAL, LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
HITACHI, LTD. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
KOELIS | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
SHEATHING TECHNOLOGIES, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Device Displays Incorrect Message | 232 |
Transducer | 207 |
Microbial Contamination Of Device | 68 |
Catheter | 25 |
Detachment Of Device Component | 24 |
Use Of Device Problem | 23 |
Incorrect, Inadequate Or Imprecise Result Or Readings | 21 |
Electrical /Electronic Property Problem | 20 |
Device Operational Issue | 20 |
Poor Quality Image | 19 |
Device Operates Differently Than Expected | 18 |
Adverse Event Without Identified Device Or Use Problem | 16 |
Computer Software Problem | 16 |
Break | 14 |
Contamination / Decontamination Problem | 13 |
Tip | 13 |
Data Problem | 12 |
Split | 12 |
Detachment Of Device Or Device Component | 12 |
Temperature Problem | 12 |
Insufficient Information | 10 |
False Negative Result | 10 |
Low Readings | 10 |
Signal Artifact | 9 |
Invalid Sensing | 9 |
Entrapment Of Device | 9 |
Output Problem | 8 |
Overheating Of Device | 8 |
Endoscope | 8 |
Fracture | 8 |
Material Separation | 7 |
Mechanical Problem | 6 |
Shaft | 6 |
No Display / Image | 5 |
Retraction Problem | 5 |
Difficult To Remove | 5 |
Loss Of Data | 5 |
Improper Device Output | 5 |
Loss Of Or Failure To Bond | 4 |
Material Puncture / Hole | 4 |
Probe | 4 |
Incorrect Or Inadequate Test Results | 4 |
Crack | 3 |
Device Damaged By Another Device | 3 |
Low Test Results | 3 |
Physical Property Issue | 3 |
Appropriate Term/Code Not Available | 3 |
Connection Problem | 3 |
Residue After Decontamination | 3 |
Smoking | 2 |
Defective Component | 2 |
Device Inoperable | 2 |
Valve | 2 |
Failure To Sense | 2 |
Computer System Security Problem | 2 |
Device Contamination With Chemical Or Other Material | 2 |
Material Fragmentation | 2 |
Hole In Material | 2 |
Device Handling Problem | 2 |
Fluid Leak | 2 |
Material Perforation | 2 |
Failure To Disconnect | 2 |
Positioning Problem | 1 |
Audible Prompt / Feedback | 1 |
Hub | 1 |
Grounding Malfunction | 1 |
Loose Or Intermittent Connection | 1 |
Disconnection | 1 |
Erratic Or Intermittent Display | 1 |
Encoder | 1 |
Failure To Align | 1 |
Torn Material | 1 |
Needle | 1 |
Failure To Disinfect | 1 |
Excess Flow Or Over-Infusion | 1 |
Unsealed Device Packaging | 1 |
Material Protrusion / Extrusion | 1 |
Device Issue | 1 |
Material Deformation | 1 |
Leak / Splash | 1 |
Bent | 1 |
Sparking | 1 |
Contamination During Use | 1 |
Material Discolored | 1 |
Application Program Problem: Parameter Calculation Error | 1 |
Product Quality Problem | 1 |
Improper Or Incorrect Procedure Or Method | 1 |
Device Sensing Problem | 1 |
Issue With Displayed Error Message | 1 |
Difficult To Flush | 1 |
Incorrect Measurement | 1 |
Seal | 1 |
No Apparent Adverse Event | 1 |
Component Missing | 1 |
Failure To Calibrate | 1 |
High Readings | 1 |
Coiled | 1 |
Optical Distortion | 1 |
| Total Device Problems | 1029 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Boston Scientific Corporation | II | Jan-30-2014 |
| 2 | CIVCO Medical Instruments Co., Inc. | II | Dec-07-2018 |
| 3 | Civco Medical Instruments Co. Inc. | II | Aug-29-2018 |
| 4 | Civco Medical Instruments Co. Inc. | II | Aug-22-2018 |
| 5 | Civco Medical Instruments Co. Inc. | II | Nov-17-2015 |
| 6 | Civco Medical Instruments Inc | II | Apr-08-2015 |
| 7 | Hitachi Medical Systems America Inc | II | Mar-01-2018 |
| 8 | Pentax Medical Company | II | Jun-28-2016 |
| 9 | Siemens Medical Solutions USA, Inc. | II | Sep-03-2014 |