SIGNA Hero
FDA 510(k) clearance K213668 · decided 2022-01-20
Clearance details
- K-number
- K213668
- Device name
- SIGNA Hero
- Applicant
- Ge Healthcare (Ge Medical Systems, LLC)
- Decision
- Substantially Equivalent
- Date received
- 2021-11-22
- Decision date
- 2022-01-20
- Days to decision
- 59 days
- Clearance type
- Traditional
- 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 |
|---|---|---|
| GE SIGNA Hero, Nuclear Magnetic Resonance Imaging System recall (Z-2308-2025) | GE Medical Systems, LLC | 2025-08-13 |
| SIGNA Hero, with affected software versions: PX29.1, MR30.0, MR30.1; Nuclear Magnetic Reso recall (Z-2461-2024) | GE Medical Systems, LLC | 2024-08-02 |