SIGNA Artist Evo
FDA 510(k) clearance K213603 · decided 2022-02-11
Clearance details
- K-number
- K213603
- Device name
- SIGNA Artist Evo
- Applicant
- Ge Healthcare (Tianjin) Company Limited
- Decision
- Substantially Equivalent
- Date received
- 2021-11-15
- Decision date
- 2022-02-11
- Days to decision
- 88 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 |
|---|---|---|
| GE SIGNA Artist Evo, Nuclear Magnetic Resonance Imaging System recall (Z-2310-2025) | GE Medical Systems, LLC | 2025-08-13 |