Cleared Traditional

K854085 - OMNI PLANE SYSTEM

K854085 is an FDA 510(k) clearance for OMNI PLANE SYSTEM, manufactured by Xre Corp.. The device is a Class 2 Radiology device with product code IXR cleared through the Traditional 510(k) pathway after a 21-day FDA review.

K854085 · Xre Corp. · Radiology device
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Oct 1985
Decision
21d
Days
Class 2
Risk

K854085 is an FDA 510(k) clearance for the OMNI PLANE SYSTEM. Classified as Table, Radiographic, Tilting (product code IXR), Class II - Special Controls.

Submitted by Xre Corp. (Littleton, US). The FDA issued a Cleared decision on October 28, 1985 after a review of 21 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1980 - 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 Xre Corp. devices

FDA 510(k) Submission Details - K854085

510(k) Number K854085 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 07, 1985
Decision Date October 28, 1985
Days to Decision 21 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
86d faster than avg
Panel avg: 107d · This submission: 21d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IXR Device Classification - Class 2, Special Controls

Product Code IXR Table, Radiographic, Tilting
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1980
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 - IXR Table, Radiographic, Tilting

All 41
Devices cleared under the same product code (IXR) and FDA review panel - the closest regulatory comparables to K854085.
OMNI DIAGNOST
K874113 · Xre Corp. · Nov 1987
TRAUMA TABLE II
K874114 · Xre Corp. · Nov 1987
SIREGRAPH D
K860913 · Siemens Medical Solutions USA, Inc. · Apr 1986
PRESTILIX 1690
K843926 · Cgr Medical Corp. · Dec 1984
TRIOSKOP
K792645 · Siemens Corp. · Jan 1980
UROSKOP A AND B
K781532 · Siemens Corp. · Sep 1978