Cleared Traditional

K893674 - RME 325R

K893674 is the FDA 510(k) clearance for RME 325R by Fischer Imaging Corp.. It is a Class 1 Radiology device (product code IZO) cleared through the Traditional 510(k) pathway after a 66-day FDA review.

K893674 · Fischer Imaging Corp. · Radiology device
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Jul 1989
Decision
66d
Days
Class 1
Risk

K893674 is an FDA 510(k) clearance for the RME 325R. Classified as Generator, High-voltage, X-ray, Diagnostic (product code IZO), Class I - General Controls.

Submitted by Fischer Imaging Corp. (Denver, US). The FDA issued a Cleared decision on July 20, 1989 after a review of 66 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.

View all Fischer Imaging Corp. devices

Submission Details

510(k) Number K893674 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 15, 1989
Decision Date July 20, 1989
Days to Decision 66 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
41d faster than avg
Panel avg: 107d · This submission: 66d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 77
Devices cleared under the same product code (IZO) and FDA review panel - the closest regulatory comparables to K893674.
KXO-80C/80D
K904043 · Toshiba America Medical Systems, In.C · Nov 1990
SHIMADZU X-RAY HIGH VOLTAGE GENERATPR AHD150G
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VPW 2877D5, X-RAY POWER SUPPLY
K902106 · Varian Assoc., Inc. · Aug 1990
MULTI PULSE POWER UNIT GENERATOR
K892943 · GE Medical Systems · May 1989
ESP 3-PHASE X-RAY GENERATORS
K884678 · Elscint, Inc. · Jan 1989
CFX 625
K883976 · Fischer Imaging Corp. · Dec 1988