Cleared Traditional

K213717 - AIR Recon DL

K213717 is an FDA 510(k) clearance for AIR Recon DL, manufactured by Ge Medical Systems,Llc (Ge Healthcare). The device is a Class 2 Radiology device with product code LNH cleared through the Traditional 510(k) pathway after a 196-day FDA review.

K213717 · Ge Medical Systems,Llc (Ge Healthcare) · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2022
Decision
196d
Days
Class 2
Risk

K213717 is an FDA 510(k) clearance for the AIR Recon DL. Classified as System, Nuclear Magnetic Resonance Imaging (product code LNH), Class II - Special Controls.

Submitted by Ge Medical Systems,Llc (Ge Healthcare) (Waukesha, US). The FDA issued a Cleared decision on June 8, 2022 after a review of 196 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Ge Medical Systems,Llc (Ge Healthcare) devices

FDA 510(k) Submission Details - K213717

510(k) Number K213717 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 24, 2021
Decision Date June 08, 2022
Days to Decision 196 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
89d slower than avg
Panel avg: 107d · This submission: 196d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LNH Device Classification - Class 2, Special Controls

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 961
Devices cleared under the same product code (LNH) and FDA review panel - the closest regulatory comparables to K213717.
i_ Field 1.5T Superconducting Magnetic Resonance Imaging System
K221025 · Mri Division,Beijing Wandong Medical Technology Co., Ltd. · Jul 2022
MAGNETOM Free.Max, MAGNETOM Free.Star
K220575 · Siemens Medical Solutions USA, Inc. · Jun 2022
Swoop Portable MR Imaging System
K221393 · Hyperfine, Inc. · Jun 2022
Achieva, Ingenia, Ingenia CX, Ingenia Elition and Ingenia Ambition MR Systems
K213583 · Philips Medical Systems Nederland B.V. · May 2022
MAGNETOM Skyra Fit
K220589 · Siemens Medical Solutions USA, Inc. · May 2022
MAGNETOM Lumina and MAGNETOM Vida Fit with syngo MR XA50A
K220939 · Siemens Medical Solutions USA, Inc. · Apr 2022