Cleared Traditional

K111445 - DISCOVERY NM 630

K111445 is an FDA 510(k) clearance for DISCOVERY NM 630, manufactured by Ge Healthcare. The device is a Class 2 Radiology device with product code KPS cleared through the Traditional 510(k) pathway after a 10-day FDA review.

K111445 · Ge Healthcare · Radiology device
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Optimized for regulatory review, auditing and printing
Jun 2011
Decision
10d
Days
Class 2
Risk

K111445 is an FDA 510(k) clearance for the DISCOVERY NM 630. Classified as System, Tomography, Computed, Emission (product code KPS), Class II - Special Controls.

Submitted by Ge Healthcare (Tirat Hacarmel, IL). The FDA issued a Cleared decision on June 3, 2011 after a review of 10 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 Healthcare devices

FDA 510(k) Submission Details - K111445

510(k) Number K111445 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 24, 2011
Decision Date June 03, 2011
Days to Decision 10 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
97d faster than avg
Panel avg: 107d · This submission: 10d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

KPS Device Classification - Class 2, Special Controls

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 Consultant

Underwriters Laboratories, Inc.

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - KPS System, Tomography, Computed, Emission

All 375
Devices cleared under the same product code (KPS) and FDA review panel - the closest regulatory comparables to K111445.
BRIVO NM 615
K113350 · Ge Healthcare · Dec 2011
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CARDIAC SCANNER AND PROCESSING SYSTEM
K110507 · Spectrum Dynamics (Israel) , Ltd. · Jul 2011
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K103710 · Ultraspect , Ltd. · Jan 2011
BIOGRAPH MCT FAMILY
K101550 · Siemens Medical Solutions USA, Inc. · Sep 2010
DISCOVERY MODEL NM/CT 670
K093514 · Ge Medical Systems F.I. Haifa · Dec 2009