Cleared Traditional

BI-PLANE DIGITAL FLUOROGRAPHY DFX7000 (K834286) - FDA 510(k) Clearance

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K834286 · Adac Laboratories · Radiology device
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Jan 1984
Decision
40d
Days
Class 2
Risk

K834286 is an FDA 510(k) clearance for the BI-PLANE DIGITAL FLUOROGRAPHY DFX7000. Classified as System, X-ray, Fluoroscopic, Image-intensified (product code JAA), Class II - Special Controls.

Submitted by Adac Laboratories (Mchenry, US). The FDA issued a Cleared decision on January 4, 1984 after a review of 40 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.

View all Adac Laboratories devices

Submission Details

510(k) Number K834286 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 25, 1983
Decision Date January 04, 1984
Days to Decision 40 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
67d faster than avg
Panel avg: 107d · This submission: 40d
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 59
Devices cleared under the same product code (JAA) and FDA review panel - the closest regulatory comparables to K834286.
LP LATERAL FLUORO POSITIONER (B5077A)
K872061 · General Electric Co. · Jun 1987
SCX SYSTEM
K862120 · General Electric Co. · Jun 1986
PET-SCOPE II IMAGE INTENSIFIER
K855213 · Philips Medical Systems (Cleveland), Inc. · Jan 1986
DIGITAL FLUOROGRAPHIC X-RAY SYSTEM
K833530 · General Electric Co. · Nov 1983
LATERAL ANGULATING FLUORO SUSPENSION
K820184 · General Electric Co. · Feb 1982
FLUORICON L300 IMAGE INTENSIFIER
K812775 · General Electric Co. · Nov 1981