INFX-8000F (INFINIX CSI AND INFINIX DPI)
FDA 510(k) clearance K081624 · decided 2008-06-23
Clearance details
- K-number
- K081624
- Device name
- INFX-8000F (INFINIX CSI AND INFINIX DPI)
- Applicant
- Toshiba America Medical Systems, In.C
- Decision
- Substantially Equivalent
- Date received
- 2008-06-10
- Decision date
- 2008-06-23
- Days to decision
- 13 days
- Clearance type
- Traditional
- Product code
- MQB
- Device class
- 2
- Regulation number
- 892.1680
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Tustin, CA, US
- Third-party review
- Yes
- 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 |
| Model CAT-850B Catheterization Table, a component of the Toshiba INFX-8000 series X-Ray In recall (Z-0331-2012) | Toshiba American Medical Systems Inc | 2011-12-01 |
| Toshiba Infinix fluoroscopy DFP-8000D Digital Radiography System with version 3.40 or high recall (Z-0005-2009) | Toshiba American Medical Systems Inc | 2009-09-28 |