SIGNA Prime
FDA 510(k) clearance K211980 · decided 2022-01-16
Clearance details
- K-number
- K211980
- Device name
- SIGNA Prime
- Applicant
- Ge Healthcare (Tianjin) Company Limited
- Decision
- Substantially Equivalent
- Date received
- 2021-06-25
- Decision date
- 2022-01-16
- Days to decision
- 205 days
- Clearance type
- Traditional
- Product code
- LNH
- Device class
- 2
- Regulation number
- 892.1000
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Tianjin, CN
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| SIGNA Prime, with affected software versions: MR30.1; Nuclear Magnetic Resonance Imaging S recall (Z-2479-2024) | GE Medical Systems, LLC | 2024-08-02 |
| GE Healthcare MR Systems, Magnetic Resonance imaging (MRI). SIGNA Premier, SIGNA Architect recall (Z-0983-2022) | GE Healthcare, LLC | 2022-04-21 |