Cleared Traditional

K852528 - BONE DENSITY CT PHANTOM

K852528 is an FDA 510(k) clearance for BONE DENSITY CT PHANTOM, manufactured by Computerized Imaging Reference Systems, Inc.. The device is a Class 1 Radiology device with product code IXG cleared through the Traditional 510(k) pathway after a 104-day FDA review.

K852528 · Computerized Imaging Reference Systems, Inc. · Radiology device
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Sep 1985
Decision
104d
Days
Class 1
Risk

K852528 is an FDA 510(k) clearance for the BONE DENSITY CT PHANTOM. Classified as Phantom, Anthropomorphic, Radiographic (product code IXG), Class I - General Controls.

Submitted by Computerized Imaging Reference Systems, Inc. (Norfolk, US). The FDA issued a Cleared decision on September 26, 1985 after a review of 104 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1950 - 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 Computerized Imaging Reference Systems, Inc. devices

FDA 510(k) Submission Details - K852528

510(k) Number K852528 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 14, 1985
Decision Date September 26, 1985
Days to Decision 104 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
3d faster than avg
Panel avg: 107d · This submission: 104d
Pathway characteristics
Predicate-based equivalence.

IXG Device Classification - Class 1, General Controls

Product Code IXG Phantom, Anthropomorphic, Radiographic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 892.1950
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.