inforMED
PSVClass II

Ultrasound Bronchoscope

Radiology · 21 CFR 892.1550

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/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).

MDR events5,860All time
Recalls2All time
Registered firms7Currently listed
510(k) clearances3All time

Recent MDR events

5,860 adverse event reports on file

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Event type breakdown

Malfunction5,475
Injury378
Death7

Most-reported manufacturers

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Shirakawa Olympus Co., Ltd.5,062Olympus Medical Systems Corp.520Aomori Olympus Co., Ltd.231Shirakawa Olympus Co., Ltd16Olympus Medical Systems Corp. Hinode Plant10Shirakawa Olympus Corp. Ltd.5Olympus Medical Systems Corp-shirakawa4Unspecified2

Recalls

2 recall events for this product code

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Registered firms

7 firms currently registered for this product code

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510(k) clearances

3 clearances for this product code

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