Philips EPIQ and Affiniti Ultrasound Systems Receive FDA 510(k) Clearance

The FDA has cleared the Philips EPIQ Series and Affiniti Series diagnostic ultrasound systems for general imaging use via the 510(k) pathway.

• Clearance applies to both the Philips EPIQ Series and Affiniti Series diagnostic ultrasound platforms.
• The FDA radiology panel reviewed the submission under the 510(k) pathway, though specific performance metrics or clinical validation numbers were not disclosed in the regulatory record.
• The device is classified under product code IYN, for diagnostic ultrasound imaging.

Automated summary

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