Cleared Traditional

K902637 - FUTURUS 2001 X-RAY GENERATOR

K902637 is an FDA 510(k) clearance for FUTURUS 2001 X-RAY GENERATOR, manufactured by Acoma Medical Imaging, Inc.. The device is a Class 1 Radiology device with product code IZO cleared through the Traditional 510(k) pathway after a 50-day FDA review.

K902637 · Acoma Medical Imaging, Inc. · Radiology device
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Aug 1990
Decision
50d
Days
Class 1
Risk

K902637 is an FDA 510(k) clearance for the FUTURUS 2001 X-RAY GENERATOR. Classified as Generator, High-voltage, X-ray, Diagnostic (product code IZO), Class I - General Controls.

Submitted by Acoma Medical Imaging, Inc. (Wheeling, US). The FDA issued a Cleared decision on August 3, 1990 after a review of 50 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1700 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K902637

510(k) Number K902637 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 14, 1990
Decision Date August 03, 1990
Days to Decision 50 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
57d faster than avg
Panel avg: 107d · This submission: 50d
Pathway characteristics
Predicate-based equivalence.

IZO Device Classification - Class 1, General Controls

Product Code IZO Generator, High-voltage, X-ray, Diagnostic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 892.1700
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 - IZO Generator, High-voltage, X-ray, Diagnostic

All 138
Devices cleared under the same product code (IZO) and FDA review panel - the closest regulatory comparables to K902637.
TEC 1410
K904397 · Bay Shore Medical Equipment Corp. · Nov 1990
SHIMADZU X-RAY HIGH VOLTAGE GENERATPR AHD150G
K903942 · Shimadzu Medical Systems · Oct 1990
VPW 2877D5, X-RAY POWER SUPPLY
K902106 · Varian Assoc., Inc. · Aug 1990
MODEL# MPC
K901951 · Amerisys · Jul 1990
U.S.I. MODEL 1012, REMOTE FLUOROSCOPIC CONTROL
K900062 · U.S. Imaging, Inc. · Feb 1990
RADKOR DXG-650R
K895969 · Radkor, Inc. · Nov 1989
K902637 · FUTURUS 2001 X-RAY GENERATOR
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