Cleared Traditional

K140380 - OPERA SWING

K140380 is an FDA 510(k) clearance for OPERA SWING, manufactured by General Medical Merate S.P.A. The device is a Class 2 Radiology device with product code JAA cleared through the Traditional 510(k) pathway after a 224-day FDA review.

K140380 · General Medical Merate S.P.A · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2014
Decision
224d
Days
Class 2
Risk

K140380 is an FDA 510(k) clearance for the OPERA SWING. Classified as System, X-ray, Fluoroscopic, Image-intensified (product code JAA), Class II - Special Controls.

Submitted by General Medical Merate S.P.A (Ormond Beach, US). The FDA issued a Cleared decision on September 26, 2014 after a review of 224 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1650 - 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 General Medical Merate S.P.A devices

FDA 510(k) Submission Details - K140380

510(k) Number K140380 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 14, 2014
Decision Date September 26, 2014
Days to Decision 224 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
117d slower than avg
Panel avg: 107d · This submission: 224d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JAA Device Classification - Class 2, Special Controls

Product Code JAA System, X-ray, Fluoroscopic, Image-intensified
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1650
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 - JAA System, X-ray, Fluoroscopic, Image-intensified

All 147
Devices cleared under the same product code (JAA) and FDA review panel - the closest regulatory comparables to K140380.
GENESIS
K151485 · Dornier Medtech America, Inc. · Jun 2015
X-RAY TV SYSTEM SONIALVISION G4
K142341 · Shimadzu Corp. · Mar 2015
GENESIS II
K133434 · Dornier Medtech America, Inc. · Nov 2014
XIDF-AWS801, ANGIO WORKSTATION, V5.31
K141541 · Toshibamedical Systems Corporation · Sep 2014
KALARE
K133553 · Toshiba America Medical Systems, In.C · Jun 2014
X-RAY TV SYSTEM SONIAL VISION G4
K131075 · Shimadzu Corp. · Mar 2014