Cleared Abbreviated

KIMAX, MODEL 1024 (K010187) - FDA 510(k) Clearance

Class II Radiology device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K010187 · Medical Metrics, Inc. · Radiology device
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Feb 2001
Decision
23d
Days
Class 2
Risk

K010187 is an FDA 510(k) clearance for the KIMAX, MODEL 1024. Classified as System, X-ray, Fluoroscopic, Image-intensified (product code JAA), Class II - Special Controls.

Submitted by Medical Metrics, Inc. (Chevy Chase, US). The FDA issued a Cleared decision on February 14, 2001 after a review of 23 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 Medical Metrics, Inc. devices

Submission Details

510(k) Number K010187 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 22, 2001
Decision Date February 14, 2001
Days to Decision 23 days
Submission Type Abbreviated
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
84d faster than avg
Panel avg: 107d · This submission: 23d
Pathway characteristics
Standards-based clearance path.

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 77
Devices cleared under the same product code (JAA) and FDA review panel - the closest regulatory comparables to K010187.
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K993038 · Toshiba America Medical Systems, In.C · Oct 1999
CAREGRAPH
K982319 · Siemens Medical Solutions USA, Inc. · Sep 1998
FLUOROSPOT COMPACT
K982028 · Siemens Medical Solutions USA, Inc. · Jul 1998