# Ultrasound Bronchoscope
> **Product code: 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).

## Market data
- **Cleared 510(k) submissions:** 3
- **Registered establishments:** 5
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=PSV)
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