Cleared Traditional

K010392 - ATHENA REMOTE CONTROLLED RF SYSTEM

K010392 is an FDA 510(k) clearance for ATHENA REMOTE CONTROLLED RF SYSTEM, manufactured by Cares Built, Inc.. The device is a Class 2 Radiology device with product code JAA cleared through the Traditional 510(k) pathway after a 32-day FDA review.

K010392 · Cares Built, Inc. · Radiology device
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Mar 2001
Decision
32d
Days
Class 2
Risk

K010392 is an FDA 510(k) clearance for the ATHENA REMOTE CONTROLLED RF SYSTEM. Classified as System, X-ray, Fluoroscopic, Image-intensified (product code JAA), Class II - Special Controls.

Submitted by Cares Built, Inc. (Keyport, US). The FDA issued a Cleared decision on March 12, 2001 after a review of 32 days - a notably fast clearance 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: 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 - K010392

510(k) Number K010392 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 08, 2001
Decision Date March 12, 2001
Days to Decision 32 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
75d faster than avg
Panel avg: 107d · This submission: 32d
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 297
Devices cleared under the same product code (JAA) and FDA review panel - the closest regulatory comparables to K010392.
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EXPEDIO 500D R&F X-RAY SYSTEM
K011624 · GE Medical Systems · Jun 2001
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K010187 · Medical Metrics, Inc. · Feb 2001
X-RAY SYSTEM XR-MX
K004037 · Karl Storz Endoscopy · Feb 2001
VFSS IMAGER, MODEL SIS-300
K000987 · Lifecare Imaging Intl., Ltd. · Jun 2000
K010392 · ATHENA REMOTE CONTROLLED RF SYSTEM
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