FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
OASIS CTL COIL, OD FLEXIBLE BODY COIL (L AND XL), AND RAPID FOOT COIL
K Number: K073310
·
Decision Jan 18, 2008
Classifications
1
FEI Numbers
75
Registration Numbers
75
Same Product Code
487
Applicant Total
11
Review Days
56
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Basic Information
- Device Name
- OASIS CTL COIL, OD FLEXIBLE BODY COIL (L AND XL), AND RAPID FOOT COIL
- K Number
- K073310
- Device Class
- FDA class 2
- Clearance Type
- Abbreviated
- Regulation Number
- 892.1000
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Hitachi Medical Corp.
- Date Received
- November 23, 2007
- Decision Date
- January 18, 2008
- 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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|---|---|---|---|
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| K013722 | MODIFICATION TO: EUB-8500 DIAGNOSTIC ULTRASOUND SCANNER | Feb 11, 2002 | Substantially Equivalent |
| K013723 | MODIFICATION TO: EUB-6500 DIAGNOSTIC ULTRASOUND SCANNER | Feb 6, 2002 | Substantially Equivalent |
| K012239 | MODIFICATIONS TO EUB-525 DIAGNOSTIC ULTRASOUND SCANNER; EUB-2000 DIAGNOSTIC ULTRASOUND SCANNER; SP-711 SONOPROBE SYSTEM | Aug 10, 2001 | Substantially Equivalent |
| K011252 | EUB-6000 DIAGNOSTIC ULTRASOUND SCANNER SP-711 SONOPROBE SYSTEM | May 30, 2001 | Substantially Equivalent |
| K926209 | EUB-555 | Jun 3, 1994 | Substantially Equivalent |
| K910268 | TRANSDUCERS, EUP-C318/V33/F334/CC331/B31/032T | Apr 15, 1991 | Substantially Equivalent |
| K827377 | MODEL LS 3000 LINEAR SCANNER | Jul 13, 1982 | Substantially Equivalent |