Cleared Traditional

K880518 - MOBILE C-ARM OMNI 325

K880518 is the FDA 510(k) clearance for MOBILE C-ARM OMNI 325 by Fischer Imaging Corp.. It is a Class 2 Radiology device (product code OXO) cleared through the Traditional 510(k) pathway after a 29-day FDA review.

K880518 · Fischer Imaging Corp. · Radiology device
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Mar 1988
Decision
29d
Days
Class 2
Risk

K880518 is an FDA 510(k) clearance for the MOBILE C-ARM OMNI 325. Classified as Image-intensified Fluoroscopic X-ray System, Mobile (product code OXO), Class II - Special Controls.

Submitted by Fischer Imaging Corp. (Denver, US). The FDA issued a Cleared decision on March 9, 1988 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1650 - 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 K880518 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 09, 1988
Decision Date March 09, 1988
Days to Decision 29 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
78d faster than avg
Panel avg: 107d · This submission: 29d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OXO Image-intensified Fluoroscopic X-ray System, Mobile
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1650
Definition Fluoroscopy Of The Human Body.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Peers - OXO Image-intensified Fluoroscopic X-ray System, Mobile

All 32
Devices cleared under the same product code (OXO) and FDA review panel - the closest regulatory comparables to K880518.
MOBILE X-RAY SYSTEM
K913525 · Siemens Medical Solutions USA, Inc. · Oct 1991
PHILIPS BV-29 IMAGING SYSTEM
K910115 · Philips Medical Systems, Inc. · Feb 1991
SXT-60F/60M MOBILE C ARM X-RAY UNIT
K896387 · Toshiba America Medical Systems, In.C · Feb 1990
FLOUROSCOPE, MOBILE C-ARM IMAGE INTENS.
K760429 · Varian Assoc., Inc. · Aug 1976