FDA 510(k)
FDA class 2
Substantially Equivalent
🇯🇵 Japan
INFX-8000C, V6.20
K Number: K152697
·
Decision Jan 15, 2016
Classifications
1
FEI Numbers
115
Registration Numbers
115
Same Product Code
300
Applicant Total
58
Review Days
116
Basic Information
- Device Name
- INFX-8000C, V6.20
- K Number
- K152697
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1650
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- TOSHIBA MEDICAL SYSTEMS CORPORATION
- Date Received
- September 21, 2015
- Decision Date
- January 15, 2016
- Product Code
- OWB
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| OWB | Interventional Fluoroscopic X-Ray System | FDA class 2 | Radiology |
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