SIGNA 7.0T
FDA 510(k) clearance K211118 · decided 2021-05-13
Clearance details
- K-number
- K211118
- Device name
- SIGNA 7.0T
- Applicant
- Ge Medical Systems, LLC
- Decision
- Substantially Equivalent
- Date received
- 2021-04-15
- Decision date
- 2021-05-13
- Days to decision
- 28 days
- Clearance type
- Special
- Product code
- LNH
- Device class
- 2
- Regulation number
- 892.1000
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Waukesha, WI, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| SIGNA 7.0T, with affected software versions: 7T29.1, MR30.1; Nuclear Magnetic Resonance Im recall (Z-2483-2024) | GE Medical Systems, LLC | 2024-08-02 |