Cleared Traditional

K820658 - LIXISCOPE - OR LIXI

K820658 is an FDA 510(k) clearance for LIXISCOPE - OR LIXI, manufactured by Lixi, Inc.. The device is a Class 2 Radiology device with product code OXO cleared through the Traditional 510(k) pathway after a 69-day FDA review.

K820658 · Lixi, Inc. · Radiology device
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May 1982
Decision
69d
Days
Class 2
Risk

K820658 is an FDA 510(k) clearance for the LIXISCOPE - OR LIXI. Classified as Image-intensified Fluoroscopic X-ray System, Mobile (product code OXO), Class II - Special Controls.

Submitted by Lixi, Inc. (Walker, US). The FDA issued a Cleared decision on May 18, 1982 after a review of 69 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 Lixi, Inc. devices

FDA 510(k) Submission Details - K820658

510(k) Number K820658 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 10, 1982
Decision Date May 18, 1982
Days to Decision 69 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
38d faster than avg
Panel avg: 107d · This submission: 69d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

OXO Device Classification - Class 2, Special Controls

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 66
Devices cleared under the same product code (OXO) and FDA review panel - the closest regulatory comparables to K820658.
MODIFIED ALPHA MC-9R C-ARM
K900967 · Instrumentarium Imaging, Inc. · May 1990
SXT-60F/60M MOBILE C ARM X-RAY UNIT
K896387 · Toshiba America Medical Systems, In.C · Feb 1990
MOBILE C-ARM OMNI 325
K880518 · Fischer Imaging Corp. · Mar 1988
FLOUROSCOPE, MOBILE C-ARM IMAGE INTENS.
K760429 · Varian Assoc., Inc. · Aug 1976