HITACHI DYNAMIC 3D IMAGING SYSTEM,SF-VA100— 510(k) K945400
Substantially EquivalentHitachi Medical Corp. of America
FDA 510(k) clearance K945400 for HITACHI DYNAMIC 3D IMAGING SYSTEM,SF-VA100, Substantially Equivalent on 1995-11-20. Applicant: Hitachi Medical Corp. of America. Device class: 2.
Clearance details
- Applicant
- Hitachi Medical Corp. of America
- Product code
- Code IZI
- Device class
- Class 2
- Regulation
- 21 CFR 892.1600
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Tarrytown, NY, US
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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.