SIGNA Hero— 510(k) K213668
Substantially EquivalentGe Healthcare (Ge Medical Systems, LLC)
FDA 510(k) clearance K213668 for SIGNA Hero, Substantially Equivalent on 2022-01-20. 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 K213668
K-number listed on FDA's recall record- Z-2308-2025 — GE SIGNA Hero, Nuclear Magnetic Resonance Imaging System
- Z-2461-2024 — SIGNA Hero, with affected software versions: PX29.1, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging System
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K213668.
Data sourced from openFDA. This site is unofficial and independent of the FDA.