Cleared Traditional

ACCENT 16, ACCENT 22 (K980322) - FDA 510(k) Clearance

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

K980322 · GE Medical Systems · Radiology device
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Optimized for regulatory review, auditing and printing
Apr 1998
Decision
87d
Days
Class 2
Risk

K980322 is an FDA 510(k) clearance for the ACCENT 16, ACCENT 22. Classified as Image-intensified Fluoroscopic X-ray System, Mobile (product code OXO), Class II - Special Controls.

Submitted by GE Medical Systems (Waukesha, US). The FDA issued a Cleared decision on April 24, 1998 after a review of 87 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 GE Medical Systems devices

Submission Details

510(k) Number K980322 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 27, 1998
Decision Date April 24, 1998
Days to Decision 87 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
20d faster than avg
Panel avg: 107d · This submission: 87d
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 27
Devices cleared under the same product code (OXO) and FDA review panel - the closest regulatory comparables to K980322.
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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