Cleared Traditional

K943805 - PRESTIGE REMOTE R & F SYSTEM MODELS H, VH & VHD

K943805 is an FDA 510(k) clearance for PRESTIGE REMOTE R & F SYSTEM MODELS H, manufactured by General Electric Co.. The device is a Class 2 Radiology device with product code JAA cleared through the Traditional 510(k) pathway after a 50-day FDA review.

K943805 · General Electric Co. · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 1994
Decision
50d
Days
Class 2
Risk

K943805 is an FDA 510(k) clearance for the PRESTIGE REMOTE R & F SYSTEM MODELS H, VH & VHD. Classified as System, X-ray, Fluoroscopic, Image-intensified (product code JAA), Class II - Special Controls.

Submitted by General Electric Co. (Milwaukee, US). The FDA issued a Cleared decision on September 23, 1994 after a review of 50 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 - K943805

510(k) Number K943805 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 04, 1994
Decision Date September 23, 1994
Days to Decision 50 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
57d faster than avg
Panel avg: 107d · This submission: 50d
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 299
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K943805 · PRESTIGE REMOTE R & F SYSTEM MODELS H, VH & VHD
Download PDF FDA Summary General Electric Co.