Data / Medical devices / Ultrasound Bronchoscope
Ultrasound Bronchoscope (PSV): 5 FDA-registered makers in 2 countries
5 establishments in 2 countries are registered with the FDA to make Ultrasound Bronchoscope (product code PSV, Class 2, 21 CFR 892.1550). 5 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 5 510(k) clearances under this code, the latest on October 15, 2026, and lists 2 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- PSV
- Device class
- 2
- Regulation
- 892.1550
- Medical specialty
- Radiology
Makers by country
| Country | Makers |
|---|---|
| Japan | 3 |
| China | 2 |
Makers of Ultrasound Bronchoscope
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Olympus Medical Systems Corp. | HACHIOJI-SHI Tokyo, Japan | Specification developer | 3 | August 27, 2026 | 0 | 0 | 0 | api.fda.gov |
| OLYMPUS MEDICAL SYSTEMS CORP. Hinode Plant | NISHITAMA-GUN Tokyo, Japan | Manufacturer | 2 | August 27, 2026 | 0 | 0 | 0 | api.fda.gov |
| Shirakawa Olympus Co., Ltd. | NISHISHIRAKAWA-GUN Fukushima, Japan | Manufacturer | 2 | September 6, 2019 | 0 | 0 | 0 | api.fda.gov |
| Micro-Tech (Nanjing) Co., Ltd. | Nanjing Jiangsu, China | Manufacturer | 1 | October 15, 2026 | 0 | 0 | 0 | api.fda.gov |
| Micro-Tech (Nanjing) Co., Ltd. | NAN JING Jiangsu, China | Manufacturer | 1 | October 15, 2026 | 0 | 0 | 0 | api.fda.gov |
Updated October 15, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.