GE 0.35T SIGNA OVATION WITH EXCITE MR SYSTEM— 510(k) K053009
Substantially EquivalentGE Medical Systems
FDA 510(k) clearance K053009 for GE 0.35T SIGNA OVATION WITH EXCITE MR SYSTEM, Substantially Equivalent on 2005-11-17. Applicant: GE Medical Systems. Device class: 2.
Clearance details
- Applicant
- GE Medical Systems
- 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
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 K053009
K-number listed on FDA's recall record- Z-0693-2019 — Various GE Magnetic Resonance System on-site software version Product Usage: Magnetic resonance imaging equipment for general diagnostic use
- Z-1209-2013 — GE Healthcare, Optima MR360/Brivo MR355 (HDsv), GE 0.35T Signa Ovation HD MR System, GE 0.2T Signa Profile HD MR System. Indicated for use as a diagnostic imaging device.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K053009.
Data sourced from openFDA. This site is unofficial and independent of the FDA.