MODEL DFP-8000D/FPD DIGITAL RADIOGRAPHY SYSTEM WITH FLAT PANEL DETECTOR
FDA 510(k) clearance K052884 · decided 2005-10-26
Clearance details
- K-number
- K052884
- Device name
- MODEL DFP-8000D/FPD DIGITAL RADIOGRAPHY SYSTEM WITH FLAT PANEL DETECTOR
- Applicant
- Toshiba America Medical Systems, In.C
- Decision
- Substantially Equivalent
- Date received
- 2005-10-13
- Decision date
- 2005-10-26
- Days to decision
- 13 days
- Clearance type
- Traditional
- Product code
- OWB
- Device class
- 2
- Regulation number
- 892.1650
- 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 |
| Toshiba-Interventional Angiography System, Infinix i, Model DFP-8000D, equiped with Digita recall (Z-0293-2008) | Toshiba American Med Sys Inc | 2007-11-27 |