INFINIX-CCI— 510(k) K113052
Substantially EquivalentToshiba America Medical Systems, In.C
FDA 510(k) clearance K113052 for INFINIX-CCI, Substantially Equivalent on 2011-11-22. Applicant: Toshiba America Medical Systems, In.C. Device class: 2.
Clearance details
- Applicant
- Toshiba America Medical Systems, In.C
- Product code
- Code MQB
- Device class
- Class 2
- Regulation
- 21 CFR 892.1680
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Tustin, CA, US
Recent devices under product code MQB
view allMore clearances from Toshiba America Medical Systems, In.C
view allRecalls naming K113052
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K113052.
Data sourced from openFDA. This site is unofficial and independent of the FDA.