FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Contour Hand/Wrist (Q7000232)
K Number: K233652
·
Decision Feb 16, 2024
Classifications
1
FEI Numbers
75
Registration Numbers
75
Same Product Code
487
Applicant Total
13
Review Days
94
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Basic Information
- Device Name
- Contour Hand/Wrist (Q7000232)
- K Number
- K233652
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1000
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Quality Electrodynamics
- Date Received
- November 14, 2023
- Decision Date
- February 16, 2024
- 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 Quality Electrodynamics
| K Number | Device Name | ||
|---|---|---|---|
| K244054 | 16ch Flex SPEEDER Medium 1.5T (Q7000246); 16ch Flex SPEEDER Large 1.5T (Q7000247) | Feb 28, 2025 | Substantially Equivalent |
| K233656 | Contour Shoulder | Feb 15, 2024 | Substantially Equivalent |
| K122638 | TOSHIBA 3T 32CH HEAD SPEEDER COIL, | Sep 25, 2012 | Substantially Equivalent |
| K120627 | TOSHIBA 1.5T QD HEAD COIL | Mar 29, 2012 | Substantially Equivalent |
| K120290 | TOSHIBA 1.5T CARDIAC COIL | Feb 28, 2012 | Substantially Equivalent |
| K112313 | TOSHIBA 3T EXTRA LARGE KNEE COIL | Sep 9, 2011 | Substantially Equivalent |
| K103185 | TOSHIBA 1.5T EXTRA LARGE KNEE COIL | Feb 25, 2011 | Substantially Equivalent |
| K093667 | SHOULDER SPEEDER COIL | Jan 28, 2010 | Substantially Equivalent |
| K091114 | TXRX 1.5T CP HEAD COIL; TXRX 3T CP HEAD COIL | May 1, 2009 | Substantially Equivalent |
| K083160 | 1.5T ATLAS SPEEDER HEAD-NECK COIL | Nov 7, 2008 | Substantially Equivalent |