Cleared Traditional

K895799 - RECTILINEAR SCANNER MODEL #187-270

K895799 is an FDA 510(k) clearance for RECTILINEAR SCANNER MODEL #187-270, manufactured by Atomic Products Corp.. The device is a Class 1 Radiology device with product code IYW cleared through the Traditional 510(k) pathway after a 126-day FDA review.

K895799 · Atomic Products Corp. · Radiology device
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Feb 1990
Decision
126d
Days
Class 1
Risk

K895799 is an FDA 510(k) clearance for the RECTILINEAR SCANNER MODEL #187-270. Classified as Scanner, Rectilinear, Nuclear (product code IYW), Class I - General Controls.

Submitted by Atomic Products Corp. (Shirley, US). The FDA issued a Cleared decision on February 1, 1990 after a review of 126 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1300 - 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 Atomic Products Corp. devices

FDA 510(k) Submission Details - K895799

510(k) Number K895799 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 28, 1989
Decision Date February 01, 1990
Days to Decision 126 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
19d slower than avg
Panel avg: 107d · This submission: 126d
Pathway characteristics
Predicate-based equivalence.

IYW Device Classification - Class 1, General Controls

Product Code IYW Scanner, Rectilinear, Nuclear
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 892.1300
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.