Cleared Traditional

K211846 - Discovery MI Gen2

K211846 is the FDA 510(k) clearance for Discovery MI Gen2 by Ge Medical Systems, LLC. It is a Class 2 Radiology device (product code KPS) cleared through the Traditional 510(k) pathway after a 66-day FDA review.

K211846 · Ge Medical Systems, LLC · Radiology device
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Aug 2021
Decision
66d
Days
Class 2
Risk

K211846 is an FDA 510(k) clearance for the Discovery MI Gen2. Classified as System, Tomography, Computed, Emission (product code KPS), Class II - Special Controls.

Submitted by Ge Medical Systems, LLC (Waukesha, US). The FDA issued a Cleared decision on August 20, 2021 after a review of 66 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1200 - 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 K211846 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 15, 2021
Decision Date August 20, 2021
Days to Decision 66 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
41d faster than avg
Panel avg: 107d · This submission: 66d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KPS System, Tomography, Computed, Emission
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1200
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 - KPS System, Tomography, Computed, Emission

All 242
Devices cleared under the same product code (KPS) and FDA review panel - the closest regulatory comparables to K211846.
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MyoSPECT, MyoSpect ES
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PET VCAR
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Vereos PET/CT
K210880 · Philips Medical Systems Nederland B.V. · May 2021