Cleared Traditional

K843917 - FLUOROSCOPIC AUTOMATIC BRIGHTNESS CNTL

K843917 is the FDA 510(k) clearance for FLUOROSCOPIC AUTOMATIC BRIGHTNESS CNTL by Afp Imaging Corp.. It is a Class 2 Radiology device (product code JAA) cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K843917 · Afp Imaging Corp. · Radiology device
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Jan 1985
Decision
90d
Days
Class 2
Risk

K843917 is an FDA 510(k) clearance for the FLUOROSCOPIC AUTOMATIC BRIGHTNESS CNTL. Classified as System, X-ray, Fluoroscopic, Image-intensified (product code JAA), Class II - Special Controls.

Submitted by Afp Imaging Corp. (Chatsworth, US). The FDA issued a Cleared decision on January 3, 1985 after a review of 90 days - within the typical 510(k) review window.

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 Afp Imaging Corp. devices

Submission Details

510(k) Number K843917 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 05, 1984
Decision Date January 03, 1985
Days to Decision 90 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
17d faster than avg
Panel avg: 107d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 136
Devices cleared under the same product code (JAA) and FDA review panel - the closest regulatory comparables to K843917.
PET-SCOPE II IMAGE INTENSIFIER
K855213 · Philips Medical Systems (Cleveland), Inc. · Jan 1986
CANON X-RAY IMAGE DISTRIBUTOR
K853984 · Canon USA, Inc. · Oct 1985
EQUIPMENT SNAP KOVERS
K850959 · Advance Medical Designs, Inc. · Apr 1985
REGISTREX 1000 PLUS DIGITAL RADIOGRAPHY
K840364 · Advanced Technology Laboratories, Inc. · Mar 1984
DIGITAL FLUOROGRAPHY X-RAY SYSTEM
K840191 · Adac Laboratories · Mar 1984
TECHNICARE MODEL 1047
K840390 · Technicare Corp. · Feb 1984