Definition: An Ultrasound Bronchoscope Is Indicated For The Ultrasonic Visualization, Diagnosis And Therapeutic Access To The Bronchial Tree Or The Lungs. If The Device Is Reusable, Validated Reprocessing Instructions And Reprocessing Validation Data For This De
| Device Type ID | 1647 |
| Device Name | Ultrasound Bronchoscope |
| Physical State | Ultrasound Bronchoscope |
| Technical Method | An Ultrasound Bronchoscope Has A Built-in Ultrasound Transducer (probe) At The Distal End. When Used With An Ultrasound Processor The Ultrasound Bronchoscope Produces Ultrasound Wave And Scans The Signals Reflected By Tissues To Generate The Ultrasou |
| Target Area | Bronchial Tree And Lungs |
| Regulation Description | Ultrasonic Pulsed Doppler Imaging System. |
| Regulation Medical Specialty | Radiology |
| Review Panel | Ear Nose & Throat |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Ophthalmic And Ear, Nose And Throat Devices (DOED) Ear, Nose, And Throat Devices Branch (ENTB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 892.1550 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | PSV |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 1647 |
| Device | Ultrasound Bronchoscope |
| Product Code | PSV |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Ultrasonic Pulsed Doppler Imaging System. |
| CFR Regulation Number | 892.1550 [🔎] |
| Device Problems | |
|---|---|
Microbial Contamination Of Device | 13 |
Adverse Event Without Identified Device Or Use Problem | 8 |
Endoscope | 7 |
Break | 4 |
Detachment Of Device Component | 1 |
Material Fragmentation | 1 |
Material Protrusion / Extrusion | 1 |
No Display / Image | 1 |
Obstruction Of Flow | 1 |
| Total Device Problems | 37 |