MARKS REFERENCE PHANTOM, MEASURE REFERENCE PHANTOM— 510(k) K002840
Substantially EquivalentThe Phantom Laboratory, Inc.
FDA 510(k) clearance K002840 for MARKS REFERENCE PHANTOM, MEASURE REFERENCE PHANTOM, Substantially Equivalent on 2000-11-17. Applicant: The Phantom Laboratory, Inc..
Clearance details
- Applicant
- The Phantom Laboratory, Inc.
- Product code
- Code IZI
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Greenwich, NY, US
Adverse events under product code IZI
product code IZI- Death
- 9
- Malfunction
- 5,312
- Total
- 5,321
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.