PHILIPS IU22 ULTRASOUND SYSTEM— 510(k) K042540
Substantially EquivalentPhilips Ultrasound, Inc.
FDA 510(k) clearance K042540 for PHILIPS IU22 ULTRASOUND SYSTEM, Substantially Equivalent on 2004-10-04. Applicant: Philips Ultrasound, Inc.. Device class: 2.
Clearance details
- Applicant
- Philips Ultrasound, Inc.
- Product code
- Code IYO
- Device class
- Class 2
- Regulation
- 21 CFR 892.1560
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Bothell, WA, US
Recent devices under product code IYO
view allMore clearances from Philips Ultrasound, Inc.
view allAdverse events under product code IYO
product code IYO- Malfunction
- 3,339
- Total
- 3,339
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 K042540
K-number listed on FDA's recall record- Z-1627-2026 — Philips X3-1 Ultrasound Transducer
- Z-2407-2025 — X3-1 Transducer Probe
- Z-2058-2025 — Philips S5-1 Transducer.
- Z-2517-2023 — 3D9-3v Transducer, accessory to Philips Ultrasound Systems: EPIQ Elite; Affiniti 30, 50, and 70; ClearVue 850; HD15; iU22; and Compact 5000
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K042540.
Data sourced from openFDA. This site is unofficial and independent of the FDA.