SIGNA 7.0T— 510(k) K211118
Substantially EquivalentGe Medical Systems, LLC
FDA 510(k) clearance K211118 for SIGNA 7.0T, Substantially Equivalent on 2021-05-13. 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 K211118
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K211118.
Data sourced from openFDA. This site is unofficial and independent of the FDA.