Browse hierarchy: [Radiology (RA)](/submissions/RA) → [Subpart B — Diagnostic Devices](/submissions/RA/subpart-b%E2%80%94diagnostic-devices) → [21 CFR 892.1550](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/892.1550) → PSV — Ultrasound Bronchoscope

# PSV · Ultrasound Bronchoscope

_Radiology · 21 CFR 892.1550 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/PSV

## Overview

- **Product Code:** PSV
- **Device Name:** Ultrasound Bronchoscope
- **Regulation:** [21 CFR 892.1550](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/892.1550)
- **Device Class:** 2
- **Review Panel:** [Radiology](/submissions/RA)

## Identification

An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

## Classification Rationale

Class II.

## Recent Cleared Devices (3 of 3)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K183525](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/PSV/K183525.md) | EVIS EUS Ultrasound Bronchofibervideoscope Olympus BF-UC190F | Olympus Medical Systems Corp. | Sep 6, 2019 | SESE |
| [K070983](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/PSV/K070983.md) | OLYMPUS XBF-UC180F-DT8 ULTRASONIC BRONCHOFIBERVIDEOSCOPE USED WITH ALOKA SSD-ALPHA 5/10 ULTRASOUND SYSTEM | Olympus Medical Systems Corporation | Jul 5, 2007 | SESE |
| [K021204](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/PSV/K021204.md) | OLYMPUS BF TYPE UM40 | Olympus Optical Co., Ltd. | May 1, 2002 | SESE |

## Top Applicants

- Olympus Optical Co., Ltd. — 1 clearance
- Olympus Medical Systems Corporation — 1 clearance
- Olympus Medical Systems Corp. — 1 clearance

---

**Source:** [https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/PSV](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/PSV)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com