Cleared Traditional

K111791 - LUMAGEM MOLECULAR BREAST IMAGING SYSTEM

K111791 is an FDA 510(k) clearance for LUMAGEM MOLECULAR BREAST IMAGING SYSTEM, manufactured by Gamma Medica-Ideas Incorporated. The device is a Class 1 Radiology device with product code IYX cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K111791 · Gamma Medica-Ideas Incorporated · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2011
Decision
88d
Days
Class 1
Risk

K111791 is an FDA 510(k) clearance for the LUMAGEM MOLECULAR BREAST IMAGING SYSTEM. Classified as Camera, Scintillation (gamma) (product code IYX), Class I - General Controls.

Submitted by Gamma Medica-Ideas Incorporated (Sunnyvale, US). The FDA issued a Cleared decision on September 23, 2011 after a review of 88 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1100 - 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.

FDA 510(k) Submission Details - K111791

510(k) Number K111791 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 27, 2011
Decision Date September 23, 2011
Days to Decision 88 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
19d faster than avg
Panel avg: 107d · This submission: 88d
Pathway characteristics
Predicate-based equivalence.

IYX Device Classification - Class 1, General Controls

Product Code IYX Camera, Scintillation (gamma)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 892.1100
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - IYX Camera, Scintillation (gamma)

All 109
Devices cleared under the same product code (IYX) and FDA review panel - the closest regulatory comparables to K111791.
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SENTINELLA 102
K110601 · General Equipment For Medical Imaging, S.A. · Mar 2011
DISCOVERY NM 750B
K102231 · Ge Medical Systems Israel, Functional Imaging · Nov 2010
K111791 · LUMAGEM MOLECULAR BREAST IMAGING SYSTEM
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