CX50 VERSION 2.0 DIAGNOSTIC ULTRASOUND SYSTEM AND TRANSDUCERS— 510(k) K091804
Substantially EquivalentPhilips Ultrasound, Inc.
FDA 510(k) clearance K091804 for CX50 VERSION 2.0 DIAGNOSTIC ULTRASOUND SYSTEM AND TRANSDUCERS, Substantially Equivalent on 2009-07-17. 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
- Andover, MA, 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 K091804
K-number listed on FDA's recall record- Z-2352-2025 — c5-1 Transducer Probe
- Z-2362-2025 — C9-3v Transducer Probe
- Z-2368-2025 — D5cwc Transducer Probe
- Z-2372-2025 — L12-3 Transducer Probe
- Z-2049-2025 — Philips C5-1 Transducer.
- Z-2054-2025 — Philips L12-3 Transducer.
- Z-2058-2025 — Philips S5-1 Transducer.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K091804.
Data sourced from openFDA. This site is unofficial and independent of the FDA.