Cleared Traditional

K893129 - CXC FFT-1 NON-TILT STAT RADIO XRAY TAB ...

K893129 is an FDA 510(k) clearance for CXC FFT-1 NON-TILT STAT RADIO XRAY TAB ..., manufactured by Continental X-Ray Corp.. The device is a Class 2 Radiology device with product code IZZ cleared through the Traditional 510(k) pathway after a 37-day FDA review.

K893129 · Continental X-Ray Corp. · Radiology device
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Jun 1989
Decision
37d
Days
Class 2
Risk

K893129 is an FDA 510(k) clearance for the CXC FFT-1 NON-TILT STAT RADIO XRAY TAB 4 WA FL TAB. Classified as Table, Radiographic, Non-tilting, Powered (product code IZZ), Class II - Special Controls.

Submitted by Continental X-Ray Corp. (Chicago, US). The FDA issued a Cleared decision on June 1, 1989 after a review of 37 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 Continental X-Ray Corp. devices

FDA 510(k) Submission Details - K893129

510(k) Number K893129 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 25, 1989
Decision Date June 01, 1989
Days to Decision 37 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
70d faster than avg
Panel avg: 107d · This submission: 37d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IZZ Device Classification - Class 2, Special Controls

Product Code IZZ Table, Radiographic, Non-tilting, Powered
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 - IZZ Table, Radiographic, Non-tilting, Powered

All 16
Devices cleared under the same product code (IZZ) and FDA review panel - the closest regulatory comparables to K893129.
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