FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MAXIM 7000 QUADRATURE EXTREMITY COIL MODEL NUMBER QEC-GEM-15A
K Number: K964820
·
Decision Feb 28, 1997
Classifications
1
FEI Numbers
75
Registration Numbers
75
Same Product Code
487
Applicant Total
4
Review Days
88
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- MAXIM 7000 QUADRATURE EXTREMITY COIL MODEL NUMBER QEC-GEM-15A
- K Number
- K964820
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1000
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Us Asia Instruments, Inc.
- Date Received
- December 2, 1996
- Decision Date
- February 28, 1997
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (MOS), ordered by most recent decision date.
0.55T 12Ch Breast Coil
FDA 510(k)
FDA Class 2
·Radiology
HD 8Ch Wrist Array
FDA 510(k)
FDA Class 2
·Radiology
GEM Flex Coil 16-L Array, 3.0T Receive Only; GEM Flex Coil 16-M Array, 3.0T Receive Only; GEM Flex Coil 16-S Array, 3.0T Receive Only
FDA 510(k)
FDA Class 2
·Radiology
Smart Fit TorsoCardiac 1.5T
FDA 510(k)
FDA Class 2
·Radiology
GEM Flex Coil 16-L Array, 1.5T Receive Only; GEM Flex Coil 16-M Array, 1.5T Receive Only; GEM Flex Coil 16-S Array, 1.5T Receive Only
FDA 510(k)
FDA Class 2
·Radiology
3.0T AIR 32CH HNA
FDA 510(k)
FDA Class 2
·Radiology