FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SENYINT PACS
K Number: K133098
·
Decision Jun 13, 2014
Classifications
1
FEI Numbers
609
Registration Numbers
609
Same Product Code
2221
Applicant Total
1
Review Days
256
Basic Information
- Device Name
- SENYINT PACS
- K Number
- K133098
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.2050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- DALIAN SENYINT DIGITAL MEDICAL SYSTEM CO., LTD.
- Date Received
- September 30, 2013
- Decision Date
- June 13, 2014
- 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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