SIGNA Premier— 510(k) K193282
Substantially EquivalentGe Healthcare (Ge Medical Systems, LLC)
FDA 510(k) clearance K193282 for SIGNA Premier, Substantially Equivalent on 2020-04-10. Applicant: Ge Healthcare (Ge Medical Systems, LLC). Device class: 2.
Clearance details
- Applicant
- Ge Healthcare (Ge Medical Systems, LLC)
- 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
- Traditional
- Location
- Waukesha, WI, US
Recent devices under product code LNH
view allMore clearances from Ge Healthcare (Ge Medical Systems, LLC)
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 K193282
K-number listed on FDA's recall record- Z-1767-2026 — SIGNA Premier systems
- Z-2304-2025 — GE SIGNA Premier, Nuclear Magnetic Resonance Imaging System
- Z-2462-2024 — SIGNA Premier, with affected software versions: RX27.0 to RX27.3, RX28.0, RX29.0 to RX29.2, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging System
- Z-1430-2022 — SIGNA Premier magnetic resonance scanner, model 5748519.
- Z-0590-2022 — GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA Premier System, nuclear magnetic resonance imaging system.
- Z-0132-2022 — SIGNA Premier nuclear magnetic resonance imaging system
- Z-2052-2021 — SIGNA Premier - Product Usage: is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K193282.
Data sourced from openFDA. This site is unofficial and independent of the FDA.