PSV · Class II — Moderate Risk (510(k) clearance required) · Radiology · 21 CFR 892.1550
Classification
FDA Product Code
PSV
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 892.1550
Review panel
EN
Medical specialty
Radiology
Submission type
1
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N
Definition
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).