SIGNA Premier
FDA 510(k) clearance K193282 · decided 2020-04-10
Clearance details
- K-number
- K193282
- Device name
- SIGNA Premier
- Applicant
- Ge Healthcare (Ge Medical Systems, LLC)
- Decision
- Substantially Equivalent
- Date received
- 2019-11-27
- Decision date
- 2020-04-10
- Days to decision
- 135 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 |
|---|---|---|
| SIGNA Premier systems recall (Z-1767-2026) | GE Healthcare LLC | 2026-04-02 |
| GE SIGNA Premier, Nuclear Magnetic Resonance Imaging System recall (Z-2304-2025) | GE Medical Systems, LLC | 2025-08-13 |
| SIGNA Premier, with affected software versions: RX27.0 to RX27.3, RX28.0, RX29.0 to RX29.2 recall (Z-2462-2024) | GE Medical Systems, LLC | 2024-08-02 |
| SIGNA Premier nuclear magnetic resonance imaging system recall (Z-0132-2022) | GE Healthcare, LLC | 2021-10-16 |
| SIGNA Premier - Product Usage: is a whole body magnetic resonance scanner designed to supp recall (Z-2052-2021) | GE Healthcare, LLC | 2021-07-12 |