EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound Systems— 510(k) K260680
Substantially EquivalentPhilips Ultrasound, LLC
FDA 510(k) clearance K260680 for EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound Systems, Substantially Equivalent on 2026-05-27. Applicant: Philips Ultrasound, LLC. Device class: 2.
Summary
This Philips Ultrasound record covers two items, EPIQ Series Diagnostic Ultrasound Systems and Affiniti Series Diagnostic Ultrasound Systems, under IYN, pulsed Doppler ultrasonic imaging systems.
Class II, 21 CFR 892.1550. Radiology is both the classification panel and the review panel. It came in as a Special 510(k).
Philips filed from Bothell, Washington. The decision came 86 calendar days after receipt (March 2 to May 27, 2026).
Clearance details
- Applicant
- Philips Ultrasound, LLC
- Product code
- Product code IYN
- Device class
- Class 2
- Regulation
- 21 CFR 892.1550
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Bothell, WA, US
Recent devices under product code IYN
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- K261617 — Diagnostic Ultrasound System (11+ models)
- K263150 — V10 Diagnostic Ultrasound System +10 more
- K261933 — Voluson Expert 18; Voluson Expert 20; Voluson Expert 22
- K262548 — EPIQ Inspira Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System
More clearances from Philips Ultrasound, LLC
view all- K262311 — Alturion Series Diagnostic Ultrasound System
- K261211 — Philips EPIQ Series Diagnostic Ultrasound System; Philips Affiniti Series Diagnostic Ultrasound System
- K260667 — Alturion Series Diagnostic Ultrasound System
- K260123 — EPIQ Series Diagnostic Ultrasound System
- K252558 — Lumify Diagnostic Ultrasound System
Adverse events under product code IYN
product code IYN- Death
- 25
- Injury
- 163
- Malfunction
- 1,538
- Other
- 4
- Total
- 1,730
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K260680
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K260680.
Data sourced from openFDA. This site is unofficial and independent of the FDA.