INFINIX CF-I/SP AND INFINIX VF-I/SP MODEL INFX-8000V— 510(k) K112054
Substantially EquivalentToshiba Medical Systems Corporation, Japan
FDA 510(k) clearance K112054 for INFINIX CF-I/SP AND INFINIX VF-I/SP MODEL INFX-8000V, Substantially Equivalent on 2011-08-05. Applicant: Toshiba Medical Systems Corporation, Japan.
Clearance details
- Applicant
- Toshiba Medical Systems Corporation, Japan
- Product code
- Code JAA
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Tustin, CA, US
Adverse events under product code JAA
product code JAA- Other
- 1
- Total
- 1
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.