Cleared Traditional

K851031 - EXPOSCOP MOBILE IMAGING SYSTEM

K851031 is an FDA 510(k) clearance for EXPOSCOP MOBILE IMAGING SYSTEM, manufactured by Euro-Electronics, Inc.. The device is a Class 2 Radiology device with product code JAA cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K851031 · Euro-Electronics, Inc. · Radiology device
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May 1985
Decision
77d
Days
Class 2
Risk

K851031 is an FDA 510(k) clearance for the EXPOSCOP MOBILE IMAGING SYSTEM. Classified as System, X-ray, Fluoroscopic, Image-intensified (product code JAA), Class II - Special Controls.

Submitted by Euro-Electronics, Inc. (Miami, US). The FDA issued a Cleared decision on May 28, 1985 after a review of 77 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 Euro-Electronics, Inc. devices

FDA 510(k) Submission Details - K851031

510(k) Number K851031 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 12, 1985
Decision Date May 28, 1985
Days to Decision 77 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
30d faster than avg
Panel avg: 107d · This submission: 77d
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 195
Devices cleared under the same product code (JAA) and FDA review panel - the closest regulatory comparables to K851031.
SCX SYSTEM
K862120 · General Electric Co. · Jun 1986
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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
STENOSCOP
K843235 · Cgr Medical Corp. · Nov 1984
REGISTREX 1000 PLUS DIGITAL RADIOGRAPHY
K840364 · Advanced Technology Laboratories, Inc. · Mar 1984