Cleared Traditional

K944150 - MICRO X-65 HF

K944150 is the FDA 510(k) clearance for MICRO X-65 HF by Fischer Imaging Corp.. It is a Class 1 Radiology device (product code IZO) cleared through the Traditional 510(k) pathway after a 22-day FDA review.

K944150 · Fischer Imaging Corp. · Radiology device
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Sep 1994
Decision
22d
Days
Class 1
Risk

K944150 is an FDA 510(k) clearance for the MICRO X-65 HF. 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 September 16, 1994 after a review of 22 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 K944150 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 25, 1994
Decision Date September 16, 1994
Days to Decision 22 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
85d faster than avg
Panel avg: 107d · This submission: 22d
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 K944150.
MICRO X-50 HF
K944147 · Fischer Imaging Corp. · Sep 1994
MICRO X-30HF
K944148 · Fischer Imaging Corp. · Sep 1994
MICRO X-80 HF
K944149 · Fischer Imaging Corp. · Sep 1994
VASCULAR MP X-RAY GENERATOR
K943652 · GE Medical Systems · Aug 1994
RSX-525HF
K943504 · Fischer Imaging Corp. · Aug 1994
MODEL VPW2877F8, MAMMO 5 POWER SUPPLY
K942778 · Varian Assoc., Inc. · Jul 1994