MINXRAY, MODELS HFP24 AND HFP40— 510(k) K060566
Substantially EquivalentMikasa X-Ray Co., Ltd.
FDA 510(k) clearance K060566 for MINXRAY, MODELS HFP24 AND HFP40, Substantially Equivalent on 2006-04-05. Applicant: Mikasa X-Ray Co., Ltd..
Clearance details
- Applicant
- Mikasa X-Ray Co., Ltd.
- Product code
- Code IZL
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Deer Field, IL, US
Adverse events under product code IZL
product code IZL- Other
- 3
- Total
- 3
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.