DAR-8000I— 510(k) K052076
Substantially EquivalentShimadzu Medical Systems
FDA 510(k) clearance K052076 for DAR-8000I, Substantially Equivalent on 2005-09-02. Applicant: Shimadzu Medical Systems.
Clearance details
- Applicant
- Shimadzu Medical Systems
- Product code
- Code IZI
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Location
- Torrance, CA, 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.