SIGNA Artist— 510(k) K202238
Substantially EquivalentGe Healthcare (Tianjin) Company Limited
FDA 510(k) clearance K202238 for SIGNA Artist, Substantially Equivalent on 2020-09-04. Applicant: Ge Healthcare (Tianjin) Company Limited. Device class: 2.
Clearance details
- Applicant
- Ge Healthcare (Tianjin) Company Limited
- Product code
- Code LNH
- Device class
- Class 2
- Regulation
- 21 CFR 892.1000
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Tianjin, CN
Recent devices under product code LNH
view allMore clearances from Ge Healthcare (Tianjin) Company Limited
view allAdverse events under product code LNH
product code LNH- Death
- 11
- Injury
- 670
- Malfunction
- 1,460
- Other
- 2
- Total
- 2,143
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K202238
K-number listed on FDA's recall record- Z-2299-2025 — GE Signa Artist, Nuclear Magnetic Resonance Imaging System
- Z-2469-2024 — SIGNA Artist, with affected software versions: DV26.0, DV27.1, DV28.1, DV29.1, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging System
- Z-0600-2022 — GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA Artist system, nuclear magnetic resonance imaging system.
- Z-0139-2022 — SIGNA Artist nuclear magnetic resonance imaging system
- Z-2061-2021 — SIGNA Artist, Nuclear Magnetic Resonance Imaging System
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K202238.
Data sourced from openFDA. This site is unofficial and independent of the FDA.