Radiology Diagnostic Ultrasound Devices
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 Device Type Must Be Included In A 510(k) Submission (82 Fr 26807, Available At Https://www. Gpo. Gov/f
Applicable Standards: No Standard Applicable. General Radiological Health Requirements Apply. [1000-1005]
| Radiation Type | Acoustic |
| Radition Safety | Abbreviated |
| Annual Reports | No |
| 1647 | Ultrasound Bronchoscope | Ultrasonic Pulsed Doppler Imaging System. |
| 1647 | Ultrasound Bronchoscope | Ultrasonic Pulsed Doppler Imaging System. |
| K183525 | EVIS EUS Ultrasound Bronchofibervideoscope Olympus BF-UC190F | Olympus Medical Systems Corp. |
| K070983 | OLYMPUS XBF-UC180F-DT8 ULTRASONIC BRONCHOFIBERVIDEOSCOPE USED WITH ALOKA SSD-ALPHA 5/10 ULTRASOUND SYSTEM | OLYMPUS MEDICAL SYSTEMS CORPORATION |
| K021204 | OLYMPUS BF TYPE UM40 | OLYMPUS OPTICAL CO., LTD. |
| 04953170356360 | Ultrasound bronchoscope |
| 04953170355677 | Ultrasound bronchoscope |
| 04953170355660 | Ultrasound bronchoscope |
| 04953170355653 | Ultrasound bronchoscope |
| 04953170355608 | Ultrasound bronchoscope |
| 04953170341830 | Ultrasound bronchoscope |
| 04953170341823 | Ultrasound bronchoscope |
| 04953170243226 | Ultrasound bronchoscope |
| 04953170399831 | Ultrasound bronchoscope |
| 04953170391378 | Ultrasound Bronchoscope |
| 04953170233210 | Ultrasound Bronchoscope |
| EVIS EXERA II ULTRASONIC BRONCHOFIBERVIDEOSCOPE | OLYMPUS MEDICAL SYSTEMS CORP. | 2020-03-11 |
| OLYMPUS ULTRASOUND BRONCHOSCOPE | UNKNOWN | 2020-03-05 |
| EVIS EXERA II ULTRASONIC BRONCHOFIBERVIDEOSCOPE | OLYMPUS MEDICAL SYSTEMS CORP. | 2020-02-13 |
| EVIS EXERA II ULTRASONIC BRONCHOFIBERVIDEOSCOPE | OLYMPUS MEDICAL SYSTEMS CORP. | 2020-02-12 |
| OLYMPUS EBUS BALLOON | OLYMPUS MEDICAL SYSTEMS CORPORATION | 2020-01-28 |
| BALLOON | OLYMPUS MEDICAL SYSTEMS CORP. | 2020-01-06 |
| EVIS EUS ULTRASOUND BRONCHOFIBERVIDEOSCOPE | OLYMPUS MEDICAL SYSTEMS CORP. | 2019-10-14 |
| BALLOON | OLYMPUS MEDICAL SYSTEMS CORP. | 2019-08-23 |
| EVIS EXERA II ULTRASONIC BRONCHOFIBERVIDEOSCOPE | OLYMPUS MEDICAL SYSTEMS CORP. | 2019-08-06 |
| EVIS EXERA II ULTRASONIC BRONCHOFIBERVIDEOSCOPE | OLYMPUS MEDICAL SYSTEMS CORP. | 2019-08-06 |
| EVIS EUS ULTRASOUND BRONCHOFIBERVIDEOSCOPE | OLYMPUS MEDICAL SYSTEMS CORP. | 2019-07-28 |
| BALLOON | OLYMPUS MEDICAL SYSTEMS CORP. | 2019-06-04 |
| BALLOON | OLYMPUS MEDICAL SYSTEMS CORP. | 2019-06-04 |
| BALLOON | OLYMPUS MEDICAL SYSTEMS CORP. | 2019-06-04 |
| BALLOON | OLYMPUS MEDICAL SYSTEMS CORP. | 2019-06-04 |
| BALLOON | OLYMPUS MEDICAL SYSTEMS CORP. | 2019-06-04 |
| EVIS EXERA II ULTRASONIC BRONCHOFIBERVIDEOSCOPE | OLYMPUS MEDICAL SYSTEMS CORP. | 2019-05-29 |
| EVIS EXERA II ULTRASONIC BRONCHOFIBERVIDEOSCOPE | OLYMPUS MEDICAL SYSTEMS CORP. | 2019-04-14 |
| BALLOON | OLYMPUS MEDICAL SYSTEMS CORP. | 2019-03-21 |
| EVIS EXERA II ULTRASONIC BRONCHOFIBERVIDEOSCOPE | OLYMPUS MEDICAL SYSTEMS CORP. | 2019-03-20 |
| EVIS EXERA II ULTRASONIC BRONCHOFIBERVIDEOSCOPE | OLYMPUS MEDICAL SYSTEMS CORP. | 2019-03-13 |
| EVIS EXERA II ULTRASONIC BRONCHOFIBERVIDEOSCOPE | OLYMPUS MEDICAL SYSTEMS CORP. | 2019-01-24 |
| BALLOON | OLYMPUS MEDICAL SYSTEMS CORP. | 2019-01-24 |
| EVIS EXERA II ULTRASONIC BRONCHOFIBERVIDEOSCOPE | OLYMPUS MEDICAL SYSTEMS CORP. | 2019-01-18 |
| EVIS EXERA II ULTRASONIC BRONCHOFIBERVIDEOSCOPE | OLYMPUS MEDICAL SYSTEMS CORP. | 2019-01-18 |
| EVIS LUCERA ULTRASONIC BRONCHOFIBERVIDEOSCOPE | OLYMPUS MEDICAL SYSTEMS CORP. | 2018-12-27 |
| EVIS EXERA II ULTRASONIC BRONCHOFIBERVIDEOSCOPE | OLYMPUS MEDICAL SYSTEMS CORP. | 2018-12-24 |
| EVIS EXERA II ULTRASONIC BRONCHOFIBERVIDEOSCOPE | OLYMPUS MEDICAL SYSTEMS CORP. | 2018-11-27 |
| EVIS EXERA II ULTRASONIC BRONCHOFIBERVIDEOSCOPE | OLYMPUS MEDICAL SYSTEMS CORP. | 2018-11-07 |
| PENTAX | HOYA CORPORATION PENTAX TOKYO OFFICE | 2018-10-05 |
| EVIS EXERA II ULTRASONIC BRONCHOFIBERVIDEOSCOPE | OLYMPUS MEDICAL SYSTEMS CORP. | 2018-10-01 |
| EVIS EXERA II ULTRASONIC BRONCHOFIBERVIDEOSCOPE | OLYMPUS MEDICAL SYSTEMS CORP. | 2018-08-28 |
| EVIS LUCERA ULTRASONIC BRONCHOFIBERVIDEOSCOPE | OLYMPUS MEDICAL SYSTEMS CORP. | 2018-08-01 |
| EVIS EXERA II ULTRASONIC BRONCHOFIBERVIDEOSCOPE | OLYMPUS MEDICAL SYSTEMS CORP. | 2018-07-23 |
| EVIS EXERA II ULTRASONIC BRONCHOFIBERVIDEOSCOPE | OLYMPUS MEDICAL SYSTEMS CORP. | 2018-07-13 |
| EVIS EXERA II ULTRASONIC BRONCHOFIBERVIDEOSCOPE | OLYMPUS MEDICAL SYSTEMS CORP. | 2018-07-13 |
| EVIS EXERA II ULTRASONIC BRONCHOFIBERVIDEOSCOPE | OLYMPUS MEDICAL SYSTEMS CORP. | 2018-07-13 |
| EVIS EXERA II ULTRASONIC BRONCHOFIBERVIDEOSCOPE | OLYMPUS MEDICAL SYSTEMS CORP. | 2018-07-13 |
| EVIS EXERA II ULTRASONIC BRONCHOFIBERVIDEOSCOPE | OLYMPUS MEDICAL SYSTEMS CORP. | 2018-06-11 |
| EVIS EXERA II ULTRASONIC BRONCHOFIBERVIDEOSCOPE | OLYMPUS MEDICAL SYSTEMS CORP. | 2018-05-11 |
| EVIS EXERA II ULTRASONIC BRONCHOFIBERVIDEOSCOPE | OLYMPUS MEDICAL SYSTEMS CORP. | 2018-05-11 |
| EVIS EXERA II ULTRASONIC BRONCHOFIBERVIDEOSCOPE | OLYMPUS MEDICAL SYSTEMS CORP. | 2018-04-26 |
| EVIS EXERA II ULTRASONIC BRONCHOFIBERVIDEOSCOPE | OLYMPUS MEDICAL SYSTEMS CORP. | 2018-04-26 |
| EVIS EXERA II ULTRASONIC BRONCHOFIBERVIDEOSCOPE | OLYMPUS MEDICAL SYSTEMS CORP. | 2018-04-23 |
| EVIS EXERA II ULTRASONIC BRONCHOFIBERVIDEOSCOPE | OLYMPUS MEDICAL SYSTEMS CORP. | 2018-04-18 |
| EVIS EXERA II ULTRASONIC BRONCHOFIBERVIDEOSCOPE | OLYMPUS MEDICAL SYSTEMS CORP. | 2018-04-04 |
| MAJ-1351 (D) BALLOON | OLYMPUS MEDICAL SYSTEMS CORP. | 2018-03-28 |
| EVIS EXERA II ULTRASONIC BRONCHOFIBERVIDEOSCOPE | OLYMPUS MEDICAL SYSTEMS CORP. | 2018-03-20 |
| EVIS LUCERA ULTRASONIC BRONCHOFIBERVIDEOSCOPE | OLYMPUS MEDICAL SYSTEMS CORP. | 2018-03-15 |
| EVIS EXERA II ULTRASONIC BRONCHOFIBERVIDEOSCOPE | OLYMPUS MEDICAL SYSTEMS CORP. | 2018-01-10 |