OLYMPUS XBF-UC180F-DT8 ULTRASONIC BRONCHOFIBERVIDEOSCOPE USED WITH ALOKA SSD-ALPHA 5/10 ULTRASOUND SYSTEM
FDA 510(k) clearance K070983 · decided 2007-07-05
Clearance details
- K-number
- K070983
- Device name
- OLYMPUS XBF-UC180F-DT8 ULTRASONIC BRONCHOFIBERVIDEOSCOPE USED WITH ALOKA SSD-ALPHA 5/10 ULTRASOUND SYSTEM
- Applicant
- Olympus Medical Systems Corporation
- Decision
- Substantially Equivalent
- Date received
- 2007-04-06
- Decision date
- 2007-07-05
- Days to decision
- 90 days
- Clearance type
- Traditional
- Product code
- PSV
- Device class
- 2
- Regulation number
- 892.1550
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Center Valley, PA, US
- Third-party review
- No
- Expedited review
- No
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|---|---|---|
| Bronchoscope - Ultrasonic: endoscopic real-time ultrasonic imaging, ultrasound guided need recall (Z-0328-2024) | Aizu Olympus Co., Ltd. | 2023-11-17 |
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