Cleared Traditional

K852648 - STARPORT MODEL H3300AA (FDA 510(k) Clearance)

Class I Radiology device.

K852648 · General Electric Co. · Radiology device
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Jan 1986
Decision
223d
Days
Class 1
Risk

K852648 is an FDA 510(k) clearance for the STARPORT MODEL H3300AA. Classified as Camera, Scintillation (gamma) (product code IYX), Class I - General Controls.

Submitted by General Electric Co. (Milwaukee, US). The FDA issued a Cleared decision on January 30, 1986 after a review of 223 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1100 - 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 General Electric Co. devices

Submission Details

510(k) Number K852648 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 21, 1985
Decision Date January 30, 1986
Days to Decision 223 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
116d slower than avg
Panel avg: 107d · This submission: 223d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code IYX Camera, Scintillation (gamma)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 892.1100
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.