Cleared Traditional

K253779 - SIGNA Sprint Select

K253779 is the FDA 510(k) clearance for SIGNA Sprint Select by Ge Medical Systems, LLC. It is a Class 2 Radiology device (product code LNH) cleared through the Traditional 510(k) pathway after a 71-day FDA review.

K253779 · Ge Medical Systems, LLC · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2026
Decision
71d
Days
Class 2
Risk

K253779 is an FDA 510(k) clearance for the SIGNA™ Sprint Select. Classified as System, Nuclear Magnetic Resonance Imaging (product code LNH), Class II - Special Controls.

Submitted by Ge Medical Systems, LLC (Waukesha, US). The FDA issued a Cleared decision on February 5, 2026 after a review of 71 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1000 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Ge Medical Systems, LLC devices

Submission Details

510(k) Number K253779 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 26, 2025
Decision Date February 05, 2026
Days to Decision 71 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
36d faster than avg
Panel avg: 107d · This submission: 71d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LNH System, Nuclear Magnetic Resonance Imaging
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1000
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Peers - LNH System, Nuclear Magnetic Resonance Imaging

All 812
Devices cleared under the same product code (LNH) and FDA review panel - the closest regulatory comparables to K253779.
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
MAGNETOM Flow.Ace
K260265 · Siemens Shenzhen Magnetic Resonance , Ltd. · Feb 2026
SIGNA™ Bolt
K253780 · Ge Medical Systems, LLC · Feb 2026
Ascent3T Neonatal Magnetic Resonance Imaging System
K253499 · Eyas Medical Imaging, Inc. · Jan 2026
AIR Recon DL
K252379 · Ge Medical Systems, LLC · Dec 2025
MAGNETOM Sola
K252838 · Siemens Healthcare GmbH · Dec 2025