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Sign in to claim this brandFujifilm Sonosite, Inc.
United States·US-MF-000001075
Last updated May 27, 2026
What Fujifilm Sonosite, Inc. makes
The company manufactures handheld extracorporeal ultrasound imaging transducers, including general-purpose, oesophageal, rectal/vaginal, and surgical variants, alongside portable ultrasound imaging systems. It also produces reusable oesophageal transducers, rechargeable battery packs, battery chargers, and transport trolleys for electromechanical devices.
These products are regulated under Class I, Class II, and Class IIa classifications, with listings in the EU’s eudamed database, the FDA’s 510(k) premarket notification records, and the FDA’s Unique Device Identifier (UDI) database. The company is based in the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Fujifilm Sonosite, Inc. primarily manufacture?
Fujifilm Sonosite, Inc. specializes in extracorporeal ultrasound imaging devices, including handheld transducers for general-purpose, oesophageal, rectal/vaginal, and surgical use. They also produce portable ultrasound imaging systems, reusable oesophageal transducers, battery chargers for noninvasive devices, rechargeable battery packs, and transport trolleys for electromechanical systems. These products are designed for point-of-care and procedural imaging applications.
Where is Fujifilm Sonosite, Inc. based, and how does this affect its regulatory landscape?
Fujifilm Sonosite, Inc. is based in the United States, which means its devices are subject to FDA regulations in the US market. Internationally, the company’s products are also listed in the EU’s eudamed database, indicating compliance with EU regulatory requirements. The US-based origin influences device classification (Class I, Class II, and Class IIa) and ensures alignment with both FDA and EU regulatory frameworks.
Which regulatory registries list Fujifilm Sonosite, Inc.’s devices, and why is this important?
Fujifilm Sonosite, Inc.’s devices are listed in three key registries: the EU’s eudamed database, the FDA’s 510(k) premarket notification records, and the FDA’s Unique Device Identifier (UDI) database. These listings are important because they demonstrate regulatory compliance and traceability. The eudamed entry confirms EU market access, while the FDA records (510(k) and UDI) provide transparency on device authorisation status and identification in the US market.
How are Fujifilm Sonosite, Inc.’s devices classified under medical device regulations?
Fujifilm Sonosite, Inc.’s devices fall under Class I, Class II, and Class IIa classifications. Class I devices generally pose the lowest risk and may require general controls, while Class II devices involve special controls due to moderate risk (e.g., ultrasound systems). Class IIa is a subset of Class II with additional safeguards. The classification depends on factors like device purpose, risk level, and intended use, ensuring appropriate regulatory oversight.
Why are some of Fujifilm Sonosite, Inc.’s devices listed in the FDA’s 510(k) registry?
Devices listed in the FDA’s 510(k) registry have undergone a premarket notification process, which demonstrates that the manufacturer has shown their device is substantially equivalent to a legally marketed predicate device. This classification is required for Class II and some Class IIa devices to ensure safety and effectiveness before commercial distribution in the US. The registry provides transparency on these authorisations.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- United States
- Address
- 21919 30th Dr SE, Bothell, United States
- Website
- www.sonosite.com
- —
- —
- [email protected]
- Phone
- +1(999)999-9999
- PRRC Contact
- Anoush Frankian
- EUDAMED SRN
- US-MF-000001075
- FDA FEI Number
- —
- DUNS Number
- 014438860
Catalogue (951)
Page 3 of 20| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| SonoSite S-Series | P09417-69 | FDA UDI | Class II | Active |
| SonoSite Edge II | P23610-10 | FDA UDI | Class II | Active |
| SonoSite NanoMaxx | P11111-46R | FDA UDI | Class II | Active |
| Sonosite ST Stand | P31204-20 | FDA UDI | Class II | Active |
| SonoSite Edge II | 1 | FDA UDI | Class II | Active |
| Hfl38 | P07632-15A | FDA UDI | Class II | Active |
| L38v/10-5 MHz | P26082-02 | FDA UDI | Class II | Active |
| SonoSite X-Porte | P19220-05Â | FDA UDI | Class II | Active |
| SonoSite Edge | P15000-67R | FDA UDI | Class II | Active |
| SonoSite Edge | P28961-68R | FDA UDI | Class II | Active |
| L25n/13-6 MHz | P12092-85A | FDA UDI | Class II | Active |
| Rc60xi/5-2 Mhz | P26002-03 | FDA UDI | Class II | Active |
| SonoSite iViz | 1 | FDA UDI | Class II | Active |
| SonoSite iViz | P20830-21 | FDA UDI | Class II | Active |
| SonoSite SII | P20500-13R | FDA UDI | Class II | Active |
| SonoSite Edge | P15000-14R | FDA UDI | Class II | Active |
| Battery | P15051-27 | FDA UDI | Class II | Active |
| SonoSite Edge | P15000-68 | FDA UDI | Class II | Active |
| Sonosite PX | P25000-50 | FDA UDI | Class II | Active |
| SonoSite S-Series | P09417-94 | FDA UDI | Class II | Active |
| FC1 Ultrasound System | P16951-18 | FDA UDI | Class II | Active |
| L25v/13-6 Mhz | P29277-02 | FDA UDI | Class II | Active |
| SonoSite Edge | P15000-22 | FDA UDI | Class II | Active |
| SonoSite SII | P23620-14R | FDA UDI | Class II | Active |
| C60xp/5-2 MHz | P24301-02 | FDA UDI | Class II | Active |
| SonoSite S-Series | P09417-95R | FDA UDI | Class II | Active |
| C35xp/8-3 MHz | P19617-20A | FDA UDI | Class II | Active |
| FC1 Ultrasound System | P28000-01 | FDA UDI | Class II | Active |
| ICTx/8-5 MHz | P24312-04 | FDA UDI | Class II | Active |
| SonoSite Edge | P15000-63 | FDA UDI | Class II | Active |
| SonoSite Edge II | P23610-12 | FDA UDI | Class II | Active |
| C11x/8-5 MHz | P24308-04 | FDA UDI | Class II | Active |
| FC1 Ultrasound System | P16951-26 | FDA UDI | Class II | Active |
| TEEx/8-3 MHz | P05183-18 | FDA UDI | Class II | Active |
| Edge Mini-Dock | P30376-01 | FDA UDI | Class II | Active |
| HFL38xi/13-6 MHz | P25993-03 | FDA UDI | Class II | Active |
| rP19x/5-1 MHz | P21015-10A | EUDAMEDFDA UDI | Class IIa | Active |
| L25x/13-6 MHz | P22950-10 | EUDAMEDFDA UDI | Class IIa | Active |
| rC60xi/5-2 MHz | rC60xi/5-2 MHz Armored | EUDAMEDFDA UDI | Class IIa | Active |
| rP19x/5-1 MHz | P30369-01 | EUDAMEDFDA UDI | Class IIa | Active |
| SonoSite M-Turbo | P08189-92 | EUDAMEDFDA UDI | Class IIa | Active |
| P21v/5-1 MHz | P18800-50 | EUDAMEDFDA UDI | Class IIa | Active |
| Battery | P15051-25 | EUDAMEDFDA UDI | Class I | Active |
| C60e/5-2 Mhz | P07633-21A | EUDAMEDFDA UDI | Class IIa | Active |
| L13-6 | P30257-20 | EUDAMEDFDA UDI | Class IIa | Active |
| C60xi/5-2 Mhz | P20402-20A | EUDAMEDFDA UDI | Class IIa | Active |
| Battery | P31137-01 | EUDAMED | Class I | Active |
| SLAx/13-6 MHz | P24523-01 | EUDAMEDFDA UDI | Class IIa | Active |
| C11x/8-5 MHz | P07678-70 | EUDAMEDFDA UDI | Class IIa | Active |
| L38n/10-5 MHz | P11877-70 | EUDAMEDFDA UDI | Class IIa | Active |
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