Cleared Traditional

K853175 - REI-90/15

K853175 is an FDA 510(k) clearance for REI-90/15, manufactured by Radiological Engineering, Inc.. The device is a Class 2 Radiology device with product code IXR cleared through the Traditional 510(k) pathway after a 72-day FDA review.

K853175 · Radiological Engineering, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1985
Decision
72d
Days
Class 2
Risk

K853175 is an FDA 510(k) clearance for the REI-90/15. Classified as Table, Radiographic, Tilting (product code IXR), Class II - Special Controls.

Submitted by Radiological Engineering, Inc. (North Ft. Myers, US). The FDA issued a Cleared decision on October 10, 1985 after a review of 72 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 Radiological Engineering, Inc. devices

FDA 510(k) Submission Details - K853175

510(k) Number K853175 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 30, 1985
Decision Date October 10, 1985
Days to Decision 72 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
35d faster than avg
Panel avg: 107d · This submission: 72d
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 49
Devices cleared under the same product code (IXR) and FDA review panel - the closest regulatory comparables to K853175.
TRAUMA TABLE II
K874114 · Xre Corp. · Nov 1987
SIREGRAPH D
K860913 · Siemens Medical Solutions USA, Inc. · Apr 1986
OMNI PLANE SYSTEM
K854085 · Xre Corp. · Oct 1985
PRESTILIX 1690
K843926 · Cgr Medical Corp. · Dec 1984
HILO TRANS-X TRAUMA TRANSPORT
K792326 · Tecnomed, Inc. · Jan 1980
TRIOSKOP
K792645 · Siemens Corp. · Jan 1980