Search Results

Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Intraluminal ultrasound for upper airways and tracheobronchial tree.

This subject device has been designed to be used with an OLYMPUS endoscopic ultrasound center, light source, documentation equipment, display monitor, endotherapy accessories and other ancillary equipment for endoscopic ultrasonic imaging of the upper airways and trancheobronchial tree.

The provided text is a 510(k) summary for the Olympus BF Type UM40 Ultrasonic Bronchofiberscope. It does not contain information about acceptance criteria or specific study results that prove the device meets acceptance criteria.

The document primarily focuses on establishing substantial equivalence to previously cleared predicate devices for regulatory approval. It mentions the intended use, device description, and technological characteristics, but it does not delve into performance metrics, test sets, ground truth establishment, or statistical analyses typically found in a study proving acceptance criteria.

Therefore, I cannot populate the requested table or sections regarding acceptance criteria and study details based on the provided text. The document is a regulatory submission for market clearance, not a scientific study report.

Ask a specific question about this device