GE 1.5T SIGNA HDE MR SYSTEM— 510(k) K052978
Substantially EquivalentGe Medical Systems, LLC
FDA 510(k) clearance K052978 for GE 1.5T SIGNA HDE MR SYSTEM, Substantially Equivalent on 2005-11-09. Applicant: Ge Medical Systems, LLC. Device class: 2.
Clearance details
- Applicant
- 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
- Special
- Location
- Waukesha, WI, US
Recent devices under product code LNH
view allMore clearances from 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 K052978
K-number listed on FDA's recall record- Z-0609-2022 — GE Healthcare MR superconducting magnets, a component of GE Healthcare 1.5T SIGNA HDe MR System, nuclear magnetic resonance imaging system.
- Z-1208-2013 — GE Healthcare, GE 1.5T SIGNA HDe MR SYSTEM. Indicated for use as a diagnostic imaging device.
- Z-0935-2013 — Optima MR450w, Discovery MR450, Discovery MR750, Signa HDx, Signa HDxt, Signa HDi, Signa Vibrant, and GE 1.5T Signa HDe MR System. The GE Signa HDx MR system is a whole body magnetic resonance scanner.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K052978.
Data sourced from openFDA. This site is unofficial and independent of the FDA.