Cleared Traditional

K844218 - TOMOGRAPHIC GANTRY

K844218 is an FDA 510(k) clearance for TOMOGRAPHIC GANTRY, manufactured by General Electric Co.. The device is a Class 1 Radiology device with product code IYX cleared through the Traditional 510(k) pathway after a 121-day FDA review.

K844218 · General Electric Co. · Radiology device
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Mar 1985
Decision
121d
Days
Class 1
Risk

K844218 is an FDA 510(k) clearance for the TOMOGRAPHIC GANTRY. 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 March 1, 1985 after a review of 121 days - within the typical 510(k) review window.

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

FDA 510(k) Submission Details - K844218

510(k) Number K844218 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 31, 1984
Decision Date March 01, 1985
Days to Decision 121 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
14d slower than avg
Panel avg: 107d · This submission: 121d
Pathway characteristics
Predicate-based equivalence.

IYX Device Classification - Class 1, General Controls

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.

Regulatory Peers - IYX Camera, Scintillation (gamma)

All 80
Devices cleared under the same product code (IYX) and FDA review panel - the closest regulatory comparables to K844218.
SATURN NUCLEAR MEDICINE COMPUTER SYSTEM
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BASICAM COUNTER BALANCE CAMERA
K850463 · Siemens Gammasonics, Inc. · Apr 1985
ORBITOR II COUNTER BALANCE CAMERA
K850397 · Siemens Gammasonics, Inc. · Mar 1985
NUCLEAR 700 MEDICINE MECHANICAL POSIT-
K843716 · Technicare Corp. · Dec 1984
MAXICAMERA 400 AC
K841906 · General Electric Co. · Jul 1984
DIGITAL PROCESSING SYSTEM
K840052 · Adac Laboratories · Mar 1984