SIGNA Bolt— 510(k) K253780
Substantially EquivalentGe Medical Systems, LLC
FDA 510(k) clearance K253780 for SIGNA Bolt, Substantially Equivalent on 2026-02-06. Applicant: Ge Medical Systems, LLC. Device class: 2.
Summary
GE Medical Systems' SIGNA Bolt is filed under product code LNH, nuclear magnetic resonance imaging system. The record doesn't describe the system beyond its name and that code name.
Class II, 21 CFR 892.1000. Radiology is both the classification panel and the review panel. It came in as a Traditional 510(k).
GE Medical Systems filed from Waukesha, Wisconsin. FDA found it substantially equivalent 72 calendar days after receipt (November 26, 2025 to February 6, 2026).
Clearance details
- Applicant
- Ge Medical Systems, LLC
- Product code
- Product 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 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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.