Cleared Traditional

3 PHASE HIGH FREQ. DIAG. X-RAY GEN. MICRO-X 60HF (K880525) - FDA 510(k) Clearance

Class I Radiology device.

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

Submission Details

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
Regulatory Context
Review time vs. panel average
81d slower than avg
Panel avg: 107d · This submission: 188d
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 26
Devices cleared under the same product code (IZO) and FDA review panel - the closest regulatory comparables to K880525.
POLYDOROS XS50 AND SX80
K923786 · Siemens Medical Solutions USA, Inc. · Dec 1992
MPG 65-80-100 X-RAY GENERATOR AND CONTROL
K921951 · General Electric Co. · Jul 1992
MULTI PULSE POWER UNIT GENERATOR
K892943 · GE Medical Systems · May 1989
SMX GENERATOR
K862800 · General Electric Co. · Aug 1986
MVP GENERATOR, CATALOG NO. H8018
K862682 · General Electric Co. · Jul 1986
SRX 200 DIAGNOSTIC X-RAY, HIGH VOLTAGE GENERATOR
K850823 · Philips Medical Systems (Cleveland), Inc. · Apr 1985