Cleared Traditional

SIGNA? Bolt

K253780 · Ge Medical Systems, LLC · Radiology
Feb 2026
Decision
72d
Days
Class 2
Risk

About This 510(k) Submission

K253780 is an FDA 510(k) clearance for the SIGNA? Bolt, a System, Nuclear Magnetic Resonance Imaging (Class II — Special Controls, product code LNH), submitted by Ge Medical Systems, LLC (Waukesha, US). The FDA issued a Cleared decision on February 6, 2026, 72 days after receiving the submission on November 26, 2025. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1000.

Submission Details

510(k) Number K253780 FDA.gov
FDA Decision Cleared SESE
Date Received November 26, 2025
Decision Date February 06, 2026
Days to Decision 72 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code LNH — System, Nuclear Magnetic Resonance Imaging
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1000

Similar Devices — LNH System, Nuclear Magnetic Resonance Imaging

All 1093
Embrace Neonatal MRI System
K254277 · Aspect Imaging, Ltd. · Mar 2026
LiverMultiScan (v6.0)
K253413 · Perspectum, Ltd. · Mar 2026
Magnifico Open (100009900)
K251901 · Esaote, S.P.A. · Mar 2026
MAGNETOM Flow.Ace; MAGNETOM Flow.Plus
K260265 · Siemens Shenzhen Magnetic Resonance , Ltd. · Feb 2026
Ingenia, Ingenia CX, Ingenia Elition S/X, Ingenia Ambition S/X, BlueSeal SE/XE/QE, MR 5300 and MR 7700 MR Systems including Upgrades
K253648 · Philips Medical Systems Nederland B.V. · Feb 2026
SIGNA? Sprint Select
K253779 · Ge Medical Systems, LLC · Feb 2026