Cleared Traditional

LIXISCOPE - OR LIXI (K820658) - FDA 510(k) Clearance

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

K820658 · Lixi, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

Submission Details

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.

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.