HD11 DIAGNOSTIC ULTRASOUND SYSTEM— 510(k) K062247
Substantially EquivalentPhilips Ultrasound, Inc.
FDA 510(k) clearance K062247 for HD11 DIAGNOSTIC ULTRASOUND SYSTEM, Substantially Equivalent on 2006-08-18. 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
- Andover, MA, 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 K062247
K-number listed on FDA's recall record- Z-2356-2025 — C6-3 Transducer Probe
- Z-2403-2025 — V6-2 Transducer Probe
- Z-2062-2025 — Philips V6-2 Transducer.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K062247.
Data sourced from openFDA. This site is unofficial and independent of the FDA.