FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
QUADRATURE CERVICAL CONTOUR COIL
K Number: K923881
·
Decision Nov 5, 1992
Classifications
1
FEI Numbers
152
Registration Numbers
152
Same Product Code
1071
Applicant Total
9
Review Days
93
Basic Information
- Device Name
- QUADRATURE CERVICAL CONTOUR COIL
- K Number
- K923881
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1000
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- MAGNETIC RESEARCH, INC.
- Date Received
- August 4, 1992
- Decision Date
- November 5, 1992
- Product Code
- LNH
- 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 |
|---|---|---|---|
| LNH | System, Nuclear Magnetic Resonance Imaging | FDA class 2 | Radiology |
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Other Clearances by MAGNETIC RESEARCH, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K935015 | QUADRATURE SMALL EXTREMITY COIL | May 10, 1994 | Substantially Equivalent |
| K932552 | SPORTS MEDICINE QUADRATURE SHOULDER COIL | Feb 9, 1994 | Substantially Equivalent |
| K932091 | PHASED ARRAY/BILATERAL QUADRATURE CONTOUR COIL | Dec 14, 1993 | Substantially Equivalent |
| K931795 | TELERAD STAT | Nov 19, 1993 | Substantially Equivalent |
| K930991 | BILATERAL TEMPORAL MANDIBULAR JOINT COIL | Jun 18, 1993 | Substantially Equivalent |
| K920227 | QUADRATURE SHOULDER CONTOUR COIL | Aug 24, 1992 | Substantially Equivalent |
| K922006 | QQUADRATURE LUMBAR CONTOUR COIL | Jul 29, 1992 | Substantially Equivalent |
| K905512 | ANTERIOR NECK CONTOUR COIL | Mar 7, 1991 | Substantially Equivalent |