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. Device class: 2.
Clearance details
- Applicant
- Olympus Medical Systems Corporation
- Product code
- Code PSV
- Device class
- Class 2
- Regulation
- 21 CFR 892.1550
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Center Valley, PA, US
Recent devices under product code PSV
view allMore clearances from Olympus Medical Systems Corporation
view allAdverse 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 →
Recalls naming K070983
K-number listed on FDA's recall record- Z-0328-2024 — Bronchoscope - Ultrasonic: endoscopic real-time ultrasonic imaging, ultrasound guided needle aspiration and other endoscopic procedures within the airways, trancheobronchial tree, esophagus and surrounding organs Model Numbers: BF-UC180F, BF-UC190F.
- Z-2494-2023 — Olympus Bronchovideoscope, Models BF-UC180F & BF-UC190F.
- Z-3304-2018 — Ultrasonic Bronchoscope BF-UC180F
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K070983.
Data sourced from openFDA. This site is unofficial and independent of the FDA.