FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TRIANA, PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM
K Number: K103182
·
Decision Jan 14, 2011
Classifications
1
FEI Numbers
609
Registration Numbers
609
Same Product Code
2221
Applicant Total
11
Review Days
78
Basic Information
- Device Name
- TRIANA, PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM
- K Number
- K103182
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.2050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- GENORAY CO., LTD.
- Date Received
- October 28, 2010
- Decision Date
- January 14, 2011
- Product Code
- LLZ
- 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 |
|---|---|---|---|
| LLZ | System, Image Processing, Radiological | FDA class 2 | Radiology |
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| K092171 | VOLUX, DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM | Apr 26, 2010 | Substantially Equivalent |
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| K063121 | PORTABLE X-RAY SYSTEM, MODEL PORT-X II | Jan 11, 2007 | Substantially Equivalent |