FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HRH-127-8 HEAD ARRAY COIL FOR GE SIGNA 3T EXCITE MRI SYSTEM
K Number: K024352
·
Decision Jan 9, 2003
Classifications
1
FEI Numbers
75
Registration Numbers
75
Same Product Code
487
Applicant Total
71
Review Days
10
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Basic Information
- Device Name
- HRH-127-8 HEAD ARRAY COIL FOR GE SIGNA 3T EXCITE MRI SYSTEM
- K Number
- K024352
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 892.1000
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Mri Devices Corp.
- Date Received
- December 30, 2002
- Decision Date
- January 9, 2003
- Product Code
- MOS
- 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 |
|---|---|---|---|
| MOS | Coil, Magnetic Resonance, Specialty | FDA class 2 | Radiology |
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Other Clearances by Mri Devices Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K041286 | DYNACAD V1.0 | Jul 21, 2004 | Substantially Equivalent |
| K041481 | MODEL BBC-127 BIOPSY BREAST COIL | Jul 19, 2004 | Substantially Equivalent |
| K040349 | MODIFICATION TO HRW-127 WRIST ARRAY COIL | Mar 9, 2004 | Substantially Equivalent |
| K040348 | MODIFICATION TO HNC-127-INT NEUROVASCULAR ARRAY COIL | Mar 9, 2004 | Substantially Equivalent |
| K040288 | QSC-127-INT SHOULDER ARRAY COIL SET | Mar 5, 2004 | Substantially Equivalent |
| K033447 | CLIPLOC SOFT TISSUE MARKER 18G/100MM (4), /130MM (5 1/8), /150MM (6), MODELS 12370, 12372, 12376 | Jan 28, 2004 | Substantially Equivalent |
| K033567 | MODELS HRK-63-8 PMS AND HRK-127-8 KNEE ARRAY COILS | Nov 25, 2003 | Substantially Equivalent |
| K032576 | BIOPSY BREAST COIL, MODEL BBC | Oct 23, 2003 | Substantially Equivalent |
| K033151 | KFA-12 KNEE, FOOT, AND ANKLE ARRAY COIL | Oct 10, 2003 | Substantially Equivalent |
| K033152 | HAC-12 AND HAC-30 HEAD ARRAY COIL | Oct 10, 2003 | Substantially Equivalent |