FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MAGNETIC RESONANCE DIAGNOSTIC DEVICE, MODEL 0100140201, PEDIATRIC HEAD-SPINE COIL
K Number: K081322
·
Decision Jun 18, 2008
Classifications
1
FEI Numbers
75
Registration Numbers
75
Same Product Code
478
Applicant Total
8
Review Days
37
Basic Information
- Device Name
- MAGNETIC RESONANCE DIAGNOSTIC DEVICE, MODEL 0100140201, PEDIATRIC HEAD-SPINE COIL
- K Number
- K081322
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1000
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- SHANGHAI CHENGUANG MEDICAL TECHNOLOGIES CO, LTD
- Date Received
- May 12, 2008
- Decision Date
- June 18, 2008
- Product Code
- MOS
- 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 |
|---|---|---|---|
| MOS | Coil, Magnetic Resonance, Specialty | FDA class 2 | Radiology |
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Other Clearances by SHANGHAI CHENGUANG MEDICAL TECHNOLOGIES CO, LTD
| K Number | Device Name | ||
|---|---|---|---|
| K112002 | CAROTID COIL | Nov 18, 2011 | Substantially Equivalent |
| K101949 | PEDIATRIC BODY-CARDIAC COIL, MODEL: 5000012601 | Jul 28, 2010 | Substantially Equivalent |
| K101858 | PEDIATRIC HEAD-SPINE COIL (MODEL:5000012701 | Jul 14, 2010 | Substantially Equivalent |
| K092962 | CAROTID COIL 5000004901 | Oct 9, 2009 | Substantially Equivalent |
| K081340 | PEDIATRIC BODY AND CARDIAC COIL, MODEL 01000140201 | Jun 18, 2008 | Substantially Equivalent |
| K071847 | MAGNETIC RESONANCE DIAGNOSTIC DEVICE, MODEL CG-KFC18-H150-AP - KNEE/FOOT/ANKLE COIL | Jul 23, 2007 | Substantially Equivalent |
| K071882 | MODEL CG-WHC18-H150-AP - WRIST HAND COIL 1.5T 4 CH, | Jul 18, 2007 | Substantially Equivalent |