Cleared Traditional

K863309 - REFURBISH DIAGNOSTIC X-RAY EQUIPMENT

K863309 is an FDA 510(k) clearance for REFURBISH DIAGNOSTIC X-RAY EQUIPMENT, manufactured by Chemarts and Assoc., Inc.. The device is a Class 2 Radiology device with product code KPR cleared through the Traditional 510(k) pathway after a 142-day FDA review.

K863309 · Chemarts and Assoc., Inc. · Radiology device
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Jan 1987
Decision
142d
Days
Class 2
Risk

K863309 is an FDA 510(k) clearance for the REFURBISH DIAGNOSTIC X-RAY EQUIPMENT. Classified as System, X-ray, Stationary (product code KPR), Class II - Special Controls.

Submitted by Chemarts and Assoc., Inc. (Frazer, US). The FDA issued a Cleared decision on January 16, 1987 after a review of 142 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1680 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Chemarts and Assoc., Inc. devices

FDA 510(k) Submission Details - K863309

510(k) Number K863309 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 27, 1986
Decision Date January 16, 1987
Days to Decision 142 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
35d slower than avg
Panel avg: 107d · This submission: 142d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KPR Device Classification - Class 2, Special Controls

Product Code KPR System, X-ray, Stationary
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1680
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 - KPR System, X-ray, Stationary

All 297
Devices cleared under the same product code (KPR) and FDA review panel - the closest regulatory comparables to K863309.
BC 1400 HAND POSITIONER
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SCX INFORMATION MANAGEMENT SYSTEM
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DIAMENTOR PATIENT X-RAY EXPOSURE INDICATOR 07302
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VRT TABLE W/INTEGRATING TUBE STAND/ELEV
K813173 · General Electric Co. · Dec 1981
DSS 500
K811934 · Philips Medical Systems (Cleveland), Inc. · Aug 1981