Identifiers
- 510(k) Number
- K903326 FDA 510(k)
- FDA Product Code
- IYO FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.1560 FDA 510(k)
- Regulation Number
- 892.1560 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Nidek US-2000 is an ultrasound imaging system used in radiology for diagnostic imaging procedures. It is designed to produce real-time ultrasound images for clinical evaluation.
The device is supplied as a reusable system intended for use in clinical settings such as hospitals and imaging centers. It requires appropriate cleaning and maintenance between uses and is not designated as sterile or single-use. The system operates under FDA 510(k) clearance (K903326) and is authorized for marketing in the United States.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K903326 | Class II | Active |
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Manufacturer
- Manufacturer
- Nidek, Inc.
Sources (1)
- FDA 510(k) K903326 24 fields · synced Sep 23, 2026