FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Sonic DL
K Number: K223523
·
Decision May 30, 2023
Classifications
1
FEI Numbers
146
Registration Numbers
146
Same Product Code
1098
Applicant Total
2
Review Days
188
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Basic Information
- Device Name
- Sonic DL
- K Number
- K223523
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1000
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Ge Medical Systems,Llc (Ge Healthcare)
- Date Received
- November 23, 2022
- Decision Date
- May 30, 2023
- 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 Medical Systems,Llc (Ge Healthcare)
| K Number | Device Name | ||
|---|---|---|---|
| K213717 | AIR Recon DL | Jun 8, 2022 | Substantially Equivalent |