SIGNA Artist
FDA 510(k) clearance K202238 · decided 2020-09-04
Clearance details
- K-number
- K202238
- Device name
- SIGNA Artist
- Applicant
- Ge Healthcare (Tianjin) Company Limited
- Decision
- Substantially Equivalent
- Date received
- 2020-08-07
- Decision date
- 2020-09-04
- 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
- Tianjin, CN
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| GE Signa Artist, Nuclear Magnetic Resonance Imaging System recall (Z-2299-2025) | GE Medical Systems, LLC | 2025-08-13 |
| SIGNA Artist, with affected software versions: DV26.0, DV27.1, DV28.1, DV29.1, MR30.0, MR3 recall (Z-2469-2024) | GE Medical Systems, LLC | 2024-08-02 |
| SIGNA Artist nuclear magnetic resonance imaging system recall (Z-0139-2022) | GE Healthcare, LLC | 2021-10-16 |
| SIGNA Artist, Nuclear Magnetic Resonance Imaging System recall (Z-2061-2021) | GE Healthcare, LLC | 2021-07-12 |