FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MODEL 405GE-64: PHASED ARRAY TMJ COIL
K Number: K944773
·
Decision Jan 25, 1995
Classifications
1
FEI Numbers
146
Registration Numbers
146
Same Product Code
1098
Applicant Total
57
Review Days
120
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Basic Information
- Device Name
- MODEL 405GE-64: PHASED ARRAY TMJ COIL
- K Number
- K944773
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1000
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Medical Advances, Inc.
- Date Received
- September 27, 1994
- Decision Date
- January 25, 1995
- 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 Medical Advances, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K023084 | MODEL 472GE-128: QUADRATURE LOWER EXTREMITY COIL | Dec 16, 2002 | Substantially Equivalent |
| K021433 | MODEL 415PH-64/42: PHASED ARRAY SHOULDER COIL | Jun 13, 2002 | Substantially Equivalent |
| K011608 | MODEL 235GE-64; MULTI PURPOSE FLEX ARRAY COIL | Aug 14, 2001 | Substantially Equivalent |
| K010074 | MODEL 455GE PHASED ARRAY WRIST COIL | Apr 3, 2001 | Substantially Equivalent |
| K003685 | MODEL 342GE-64 HIGH RESOLUTION BRAIN COIL | Dec 22, 2000 | Substantially Equivalent |
| K003144 | MODEL 205GE-64: PATHWAY MRI CAROTID ARRAY COIL | Dec 13, 2000 | Substantially Equivalent |
| K000345 | MULTI PURPOSE FLEX ARRAY COIL : MODEL 235 SERIES | Apr 11, 2000 | Substantially Equivalent |
| K991724 | QUADRATURE LOWER EXTREMITY COIL, MODEL 473PH-64 | Aug 2, 1999 | Substantially Equivalent |
| K991434 | QUADRATURE WRIST COIL, MODEL 445PH-64 | Jul 6, 1999 | Substantially Equivalent |
| K991113 | `INEAR WRIST COIL, MODEL 440GE-09 | Jun 10, 1999 | Substantially Equivalent |