SIGNA Voyager— 510(k) K161567
Substantially EquivalentGE Healthcare
FDA 510(k) clearance K161567 for SIGNA Voyager, Substantially Equivalent on 2016-09-01. Applicant: GE Healthcare. Device class: 2.
Clearance details
- Applicant
- GE Healthcare
- 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
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 K161567
K-number listed on FDA's recall record- Z-2300-2025 — GE Signa Voyager, Nuclear Magnetic Resonance Imaging System
- Z-0599-2022 — GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA Voyager and SIGNA Voyager Premier Edition system, nuclear magnetic resonance imaging system.
- Z-0138-2022 — SIGNA Voyager nuclear magnetic resonance imaging system
- Z-2062-2021 — SIGNA Voyager, Nuclear Magnetic Resonance Imaging System
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K161567.
Data sourced from openFDA. This site is unofficial and independent of the FDA.