FDA 510(k)
FDA class 2
Substantially Equivalent
🇯🇵 Japan
TRINIAS
K Number: K123508
·
Decision Feb 26, 2014
Classifications
1
FEI Numbers
115
Registration Numbers
115
Same Product Code
300
Applicant Total
4
Review Days
470
Basic Information
- Device Name
- TRINIAS
- K Number
- K123508
- Device Class
- FDA class 2
- Clearance Type
- Abbreviated
- Regulation Number
- 892.1650
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Shimadzu Corporation
- Date Received
- November 13, 2012
- Decision Date
- February 26, 2014
- 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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