Cleared Traditional

K872061 - LP LATERAL FLUORO POSITIONER (B5077A)

K872061 is the FDA 510(k) clearance for LP LATERAL FLUORO POSITIONER (B5077A) by General Electric Co.. It is a Class 2 Radiology device (product code JAA) cleared through the Traditional 510(k) pathway after a 25-day FDA review.

K872061 · General Electric Co. · Radiology device
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Jun 1987
Decision
25d
Days
Class 2
Risk

K872061 is an FDA 510(k) clearance for the LP LATERAL FLUORO POSITIONER (B5077A). 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 June 22, 1987 after a review of 25 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 General Electric Co. devices

Submission Details

510(k) Number K872061 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 28, 1987
Decision Date June 22, 1987
Days to Decision 25 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
82d faster than avg
Panel avg: 107d · This submission: 25d
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 135
Devices cleared under the same product code (JAA) and FDA review panel - the closest regulatory comparables to K872061.
CARDIAC CX
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K871127 · Adac Laboratories · May 1987
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K871119 · Canon USA, Inc. · Mar 1987