OPER SERIES OPEN TYPE PERMANENT-MAGNET MRI SYSTEM, MODEL: OPER-0.3, -0.35, -0.4
FDA 510(k) clearance K092899 · decided 2009-11-10
Clearance details
- K-number
- K092899
- Device name
- OPER SERIES OPEN TYPE PERMANENT-MAGNET MRI SYSTEM, MODEL: OPER-0.3, -0.35, -0.4
- Applicant
- Ningbo Xingaoyi Magnetism Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2009-09-21
- Decision date
- 2009-11-10
- Days to decision
- 50 days
- Clearance type
- Traditional
- Product code
- LNH
- Device class
- 2
- Regulation number
- 892.1000
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Yuyao, Zhejiang, CN
- Third-party review
- Yes
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.