Cleared Traditional

K880525 - 3 PHASE HIGH FREQ. DIAG. X-RAY GEN. MICRO-X 60HF

K880525 is an FDA 510(k) clearance for 3 PHASE HIGH FREQ. DIAG. X-RAY GEN. MIC..., manufactured by Fischer Imaging Corp.. The device is a Class 1 Radiology device with product code IZO cleared through the Traditional 510(k) pathway after a 188-day FDA review.

K880525 · Fischer Imaging Corp. · Radiology device
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Aug 1988
Decision
188d
Days
Class 1
Risk

K880525 is an FDA 510(k) clearance for the 3 PHASE HIGH FREQ. DIAG. X-RAY GEN. MICRO-X 60HF. 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 August 15, 1988 after a review of 188 days - an extended review 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: 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 Fischer Imaging Corp. devices

FDA 510(k) Submission Details - K880525

510(k) Number K880525 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 09, 1988
Decision Date August 15, 1988
Days to Decision 188 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
81d slower than avg
Panel avg: 107d · This submission: 188d
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 99
Devices cleared under the same product code (IZO) and FDA review panel - the closest regulatory comparables to K880525.
ESP 3-PHASE X-RAY GENERATORS
K884678 · Elscint, Inc. · Jan 1989
CFX 625
K883976 · Fischer Imaging Corp. · Dec 1988
MICRO-X 100CP
K884134 · Fischer Imaging Corp. · Oct 1988
SHIMADZU X-RAY HIGH VOLTAGE GENERATOR UD150K
K881795 · Shimadzu Precision Instruments, Inc. · Jul 1988
SINGLE PHASE DIAG. X-RAY GENERATOR MICRO-X 650
K880519 · Fischer Imaging Corp. · May 1988
SINGLE PHASE DIAGNOSTIC X-RAY GENERATOR FX-650
K880521 · Fischer Imaging Corp. · May 1988