FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SIGNA PET/MR
K Number: K213709
·
Decision Jan 20, 2022
Classifications
1
FEI Numbers
11
Registration Numbers
11
Same Product Code
13
Applicant Total
104
Review Days
57
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Basic Information
- Device Name
- SIGNA PET/MR
- K Number
- K213709
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1200
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Ge Medical Systems, LLC
- Date Received
- November 24, 2021
- Decision Date
- January 20, 2022
- Product Code
- OUO
- 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 |
|---|---|---|---|
| OUO | Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance | FDA class 2 | Radiology |
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