FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
OPTIMA MR450W
K Number: K123522
·
Decision Mar 13, 2013
Classifications
1
FEI Numbers
146
Registration Numbers
146
Same Product Code
1098
Applicant Total
6
Review Days
118
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Basic Information
- Device Name
- OPTIMA MR450W
- K Number
- K123522
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1000
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Ge Healthcare (Ge Medical Systems, LLC)
- Date Received
- November 15, 2012
- Decision Date
- March 13, 2013
- 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 Ge Healthcare (Ge Medical Systems, LLC)
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|---|---|---|---|
| K213668 | SIGNA Hero | Jan 20, 2022 | Substantially Equivalent |
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| K193282 | SIGNA Premier | Apr 10, 2020 | Substantially Equivalent |
| K143251 | SIGNA Creator, SIGNA Explorer | Feb 4, 2015 | Substantially Equivalent |
| K132376 | DISCOVERY MR750 3.0T, DISCOVERY MR450 1.5T, DISCOVERY MR750W 3.0T, OPTIMA MR450W 1.5T | Nov 15, 2013 | Substantially Equivalent |