CX50 DIAGNOSTIC ULTRASOUND SYSTEM— 510(k) K081802
Substantially EquivalentPhilips Ultrasound, Inc.
FDA 510(k) clearance K081802 for CX50 DIAGNOSTIC ULTRASOUND SYSTEM, Substantially Equivalent on 2008-07-11. Applicant: Philips Ultrasound, Inc.. Device class: 2.
Clearance details
- Applicant
- Philips Ultrasound, Inc.
- Product code
- Code ITX
- Device class
- Class 2
- Regulation
- 21 CFR 892.1570
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Bothell, WA, US
Recent devices under product code ITX
view allMore clearances from Philips Ultrasound, Inc.
view allAdverse events under product code ITX
product code ITX- Death
- 6
- Injury
- 137
- Malfunction
- 2,036
- Total
- 2,179
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 K081802
K-number listed on FDA's recall record- Z-2366-2025 — D2cwc Transducer Probe
- Z-2412-2025 — X7-2t Transducer Probe
- Z-2058-2025 — Philips S5-1 Transducer.
- Z-2066-2025 — Philips X7-2t Transducer.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K081802.
Data sourced from openFDA. This site is unofficial and independent of the FDA.