INFINIX-CCI
FDA 510(k) clearance K113052 · decided 2011-11-22
Clearance details
- K-number
- K113052
- Device name
- INFINIX-CCI
- Applicant
- Toshiba America Medical Systems, In.C
- Decision
- Substantially Equivalent
- Date received
- 2011-10-13
- Decision date
- 2011-11-22
- Days to decision
- 40 days
- Clearance type
- Special
- Product code
- MQB
- Device class
- 2
- Regulation number
- 892.1680
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Tustin, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Toshiba Infinix-i X-Ray System. A radiographic and fluoroscopic x-ray system for use in di recall (Z-0994-2013) | Toshiba American Medical Systems Inc | 2013-03-25 |