PHILIPS EASY VISION FAMILY WORKSTATION OPTION MR QUANTITATIVE FLOW— 510(k) K003459
Substantially EquivalentPhilips Medical Systems North America, Inc.
FDA 510(k) clearance K003459 for PHILIPS EASY VISION FAMILY WORKSTATION OPTION MR QUANTITATIVE FLOW, Substantially Equivalent on 2001-01-22. Applicant: Philips Medical Systems North America, Inc..
Clearance details
- Applicant
- Philips Medical Systems North America, Inc.
- Product code
- Code LLZ
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Shelton, CT, US
Adverse events under product code LLZ
product code LLZ- Death
- 13
- Total
- 13
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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.