FDA 510(k)
FDA class 2
Substantially Equivalent
🇯🇵 Japan
Infinix INFX-8000V, V6.40
K Number: K170909
·
Decision Jun 16, 2017
Classifications
1
FEI Numbers
118
Registration Numbers
118
Same Product Code
319
Applicant Total
2
Review Days
80
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Basic Information
- Device Name
- Infinix INFX-8000V, V6.40
- K Number
- K170909
- 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 Coroporation
- Date Received
- March 28, 2017
- Decision Date
- June 16, 2017
- 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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Other Clearances by Toshiba Medical Systems Coroporation
| K Number | Device Name | ||
|---|---|---|---|
| K172188 | Aquilion Prime SP, TSX-303B/1, v8.4 | Oct 6, 2017 | Substantially Equivalent |