SIGNA Pioneer— 510(k) K153003
Substantially EquivalentGE Healthcare
FDA 510(k) clearance K153003 for SIGNA Pioneer, Substantially Equivalent on 2015-10-27. 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
- Special
- 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 K153003
K-number listed on FDA's recall record- Z-2460-2024 — SIGNA Pioneer, with affected software versions: PX25.0 to PX25.5, PX26.0, PX26.1, PX28.0 to PX28.4, PX29.0, PX29.1, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging System
- Z-0592-2022 — GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA Pioneer System, nuclear magnetic resonance imaging system.
- Z-0134-2022 — SIGNA Pioneer nuclear magnetic resonance imaging system
- Z-2054-2021 — SIGNA Pioneer - Product Usage: is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times.
- Z-0876-2020 — SIGNA Pioneer Nuclear Magnetic Resonance Imaging System - 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 K153003.
Data sourced from openFDA. This site is unofficial and independent of the FDA.