FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
I OPEN 0.5T
K Number: K090873
·
Decision Apr 10, 2009
Classifications
1
FEI Numbers
146
Registration Numbers
146
Same Product Code
1098
Applicant Total
2
Review Days
10
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Basic Information
- Device Name
- I OPEN 0.5T
- K Number
- K090873
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1000
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Beijing Wandong Medical Equipment Co., Ltd.
- Date Received
- March 31, 2009
- Decision Date
- April 10, 2009
- Product Code
- LNH
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- Third Party
- Y
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| LNH | System, Nuclear Magnetic Resonance Imaging | FDA class 2 | Radiology |
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Other Clearances by Beijing Wandong Medical Equipment Co., Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K090433 | I_OPEN 0.4T | Mar 25, 2009 | Substantially Equivalent |