EPIQ Diagnostic Ultrasound System Series, Affiniti Diagnostic Ultrasound System Series, CX50 Diagnostic Ultrasound System, Sparq Diagnostic Ultrasound System, Lumify Diagnostic Ultrasound System— 510(k) K201012
Substantially EquivalentPhilips Ultrasound, Inc.
FDA 510(k) clearance K201012 for EPIQ Diagnostic Ultrasound System Series, Affiniti Diagnostic Ultrasound System Series, CX50 Diagnostic Ultrasound System, Sparq Diagnostic Ultrasound System, Lumify Diagnostic Ultrasound System, Substantially Equivalent on 2020-05-01. Applicant: Philips Ultrasound, Inc.. Device class: 2.
Clearance details
- Applicant
- Philips Ultrasound, Inc.
- 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
view all- K261585 — Diagnostic Ultrasound System (Nuewa A20W) +10 more
- 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, Inc.
view allAdverse 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 K201012
K-number listed on FDA's recall record- Z-2354-2025 — C5-2 Lumify Transducer Probe
- Z-2374-2025 — L12-4 Lumify Transducer Probe
- Z-2392-2025 — S4-1 Lumify Transducer Probe
- Z-0070-2022 — Philips Ultrasound, Inc. Sparq, Diagnostic Ultrasound System, REF 795090, 100-240V -, 50/60 Hz, 500 VA, CE2797, Rx Only,
- Z-0071-2022 — Philips Ultrasound, Inc. Sparq, Diagnostic Ultrasound System, REF 795116, 100-240V -, 50/60 Hz, 500 VA, CE2797, Rx Only,
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K201012.
Data sourced from openFDA. This site is unofficial and independent of the FDA.