Cleared Traditional

K933134 - SPECTRUM DG-P7000 PEDIATRIC CRADLE (FDA 510(k) Clearance)

Class I Radiology device.

K933134 · Spectrum X-Ray Corp. · Radiology device
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Oct 1993
Decision
101d
Days
Class 1
Risk

K933134 is an FDA 510(k) clearance for the SPECTRUM DG-P7000 PEDIATRIC CRADLE. Classified as Cradle, Patient, Radiologic (product code KXH), Class I - General Controls.

Submitted by Spectrum X-Ray Corp. (Westville, US). The FDA issued a Cleared decision on October 7, 1993 after a review of 101 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1830 - 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 Spectrum X-Ray Corp. devices

Submission Details

510(k) Number K933134 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 28, 1993
Decision Date October 07, 1993
Days to Decision 101 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
6d faster than avg
Panel avg: 107d · This submission: 101d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KXH Cradle, Patient, Radiologic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 892.1830
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.