Cleared Traditional

OEC 902, 901 NASA II, OEC 902, 901 NASA I CCD C-ARM (K955251) - FDA 510(k) Clearance

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K955251 · Imaging Services, Inc. · Radiology device
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Apr 1996
Decision
149d
Days
Class 2
Risk

K955251 is an FDA 510(k) clearance for the OEC 902, 901 NASA II, OEC 902, 901 NASA I CCD C-ARM. Classified as Image-intensified Fluoroscopic X-ray System, Mobile (product code OXO), Class II - Special Controls.

Submitted by Imaging Services, Inc. (Burbank, US). The FDA issued a Cleared decision on April 12, 1996 after a review of 149 days - within the typical 510(k) review window.

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: 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 Imaging Services, Inc. devices

Submission Details

510(k) Number K955251 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 15, 1995
Decision Date April 12, 1996
Days to Decision 149 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
42d slower than avg
Panel avg: 107d · This submission: 149d
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 22
Devices cleared under the same product code (OXO) and FDA review panel - the closest regulatory comparables to K955251.
ACCENT 16, ACCENT 22
K980322 · GE Medical Systems · Apr 1998
SIREMOBIL CO2
K973598 · Siemens Medical Solutions USA, Inc. · Nov 1997
SIREMOBIL COMPACT
K963093 · Siemens Medical Solutions USA, Inc. · Sep 1996
STENOSCOP MOBILE FLUOROSCOPIC XRAY SYSTEM
K933447 · GE Medical Systems · Aug 1993
MOBILE X-RAY SYSTEM
K913525 · Siemens Medical Solutions USA, Inc. · Oct 1991