EVIS EUS Ultrasound Bronchofibervideoscope Olympus BF-UC190F
FDA 510(k) clearance K183525 · decided 2019-09-06
Clearance details
- K-number
- K183525
- Device name
- EVIS EUS Ultrasound Bronchofibervideoscope Olympus BF-UC190F
- Applicant
- Olympus Medical Systems Corp.
- Decision
- Substantially Equivalent
- Date received
- 2018-12-19
- Decision date
- 2019-09-06
- Days to decision
- 261 days
- Clearance type
- Traditional
- Product code
- PSV
- Device class
- 2
- Regulation number
- 892.1550
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Hachioji-Shi, JP
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| OLYMPUS XBF-UC180F-DT8 ULTRASONIC BRONCHOFIBERVIDEOSCOPE USED WITH ALOKA SSD-ALPHA 5/10 ULTRASOUND SYSTEM (K070983) | Olympus Medical Systems Corporation | 2007-07-05 |
| OLYMPUS BF TYPE UM40 (K021204) | Olympus Optical Co., Ltd. | 2002-05-01 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Bronchoscope - Ultrasonic: endoscopic real-time ultrasonic imaging, ultrasound guided need recall (Z-0328-2024) | Aizu Olympus Co., Ltd. | 2023-11-17 |