OLYMPUS XBF-UC180F-DT8 ULTRASONIC BRONCHOFIBERVIDEOSCOPE USED WITH ALOKA SSD-ALPHA 5/10 ULTRASOUND SYSTEM— 510(k) K070983
Substantially EquivalentOlympus Medical Systems Corporation
FDA 510(k) clearance K070983 for OLYMPUS XBF-UC180F-DT8 ULTRASONIC BRONCHOFIBERVIDEOSCOPE USED WITH ALOKA SSD-ALPHA 5/10 ULTRASOUND SYSTEM, Substantially Equivalent on 2007-07-05. Applicant: Olympus Medical Systems Corporation.
Clearance details
- Applicant
- Olympus Medical Systems Corporation
- Product code
- Code PSV
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Center Valley, PA, US
Adverse events under product code PSV
product code PSV- Death
- 6
- Injury
- 305
- Malfunction
- 3,705
- Total
- 4,016
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.