EPIQ , EPIQ 5, EPIQ 7, Affiniti 30, Affiniti 50 and Affiniti 70 Diagnostic Ultr…
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K181485 FDA 510(k)
- FDA Product Code
- IYN FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.1550 FDA 510(k)
- Regulation Number
- 892.1550 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The EPIQ 5, EPIQ 7, Affiniti 30, Affiniti 50, and Affiniti 70 are diagnostic ultrasound systems designed for medical imaging. These devices use high-frequency sound waves to generate real-time visual images of internal body structures, aiding in the diagnosis and monitoring of various conditions across multiple specialties.
These systems are intended for use in clinical settings such as hospitals, outpatient clinics, and diagnostic centers. Supplied as reusable medical equipment, they require proper maintenance and calibration to ensure accurate imaging. The devices are regulated under FDA 510(k) clearance and EU MDR, adhering to strict safety and performance standards. Each model varies in specifications, including probe configurations and imaging capabilities, as detailed in their respective technical documentation.
Frequently asked questions
Are these ultrasound systems designed for single-use or can they be reused in a clinical setting?
These systems are not single-use—they are reusable medical equipment intended for repeated use in clinical settings like hospitals and outpatient clinics. Since they require proper maintenance and calibration to ensure accurate imaging, they must be cleaned, disinfected, and serviced according to manufacturer guidelines to maintain performance and safety standards.
What types of clinical environments are these ultrasound systems intended for?
The EPIQ and Affiniti series are designed for clinical settings such as hospitals, outpatient clinics, and diagnostic centers. Their versatility supports imaging across multiple specialties, making them suitable for general radiology, obstetrics, cardiology, and other diagnostic applications where real-time ultrasound imaging is required.
How do I know which model (EPIQ 5, Affiniti 50, etc.) is best suited for my facility’s needs?
The models differ in probe configurations and imaging capabilities, which are detailed in their respective technical documentation. For example, the EPIQ series may offer advanced features like wider bandwidth or higher resolution, while the Affiniti models may prioritize portability or specific specialty applications. Consulting the manufacturer’s specifications or a Philips representative can help match your facility’s workflow and imaging requirements.
What regulatory pathways have these ultrasound systems undergone?
These systems are regulated under FDA 510(k) clearance (with K-number K181485) and comply with EU MDR (Medical Device Regulation). The FDA submission was reviewed by the Radiology (RA) Advisory Committee and classified as substantially equivalent (SESE) under a traditional 510(k) pathway, ensuring they meet established safety and performance standards.
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 (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K181485 | Class II | Active |
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Manufacturer
- Manufacturer
- Philips Ultrasound, Inc.
Sources (2)
- FDA 510(k) K181485 24 fields · synced Oct 6, 2026
- EUDAMED 1 fields · synced May 19, 2026