Cleared Abbreviated

K981131 - PATHFINDER MOBILE C ARM

K981131 is an FDA 510(k) clearance for PATHFINDER MOBILE C ARM, manufactured by Acoma Medical Imaging, Inc.. The device is a Class 2 Radiology device with product code OXO cleared through the Abbreviated 510(k) pathway after a 88-day FDA review.

K981131 · Acoma Medical Imaging, Inc. · Radiology device
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Jun 1998
Decision
88d
Days
Class 2
Risk

K981131 is an FDA 510(k) clearance for the PATHFINDER MOBILE C ARM. Classified as Image-intensified Fluoroscopic X-ray System, Mobile (product code OXO), Class II - Special Controls.

Submitted by Acoma Medical Imaging, Inc. (Wheeling, US). The FDA issued a Cleared decision on June 26, 1998 after a review of 88 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Acoma Medical Imaging, Inc. devices

FDA 510(k) Submission Details - K981131

510(k) Number K981131 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 30, 1998
Decision Date June 26, 1998
Days to Decision 88 days
Submission Type Abbreviated
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
19d faster than avg
Panel avg: 107d · This submission: 88d
Pathway characteristics
Standards-based clearance path.

OXO Device Classification - Class 2, Special Controls

Product Code OXO Image-intensified Fluoroscopic X-ray System, Mobile
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1650
Definition Fluoroscopy Of The Human Body.
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 - OXO Image-intensified Fluoroscopic X-ray System, Mobile

All 40
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