Cleared Traditional

K874451 - OMNIPLANE 200 FILM CHANGER SYSTEM

K874451 is an FDA 510(k) clearance for OMNIPLANE 200 FILM CHANGER SYSTEM, manufactured by Medrad, Inc.. The device is a Class 2 Radiology device with product code IZP cleared through the Traditional 510(k) pathway after a 106-day FDA review.

K874451 · Medrad, Inc. · Radiology device
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Feb 1988
Decision
106d
Days
Class 2
Risk

K874451 is an FDA 510(k) clearance for the OMNIPLANE 200 FILM CHANGER SYSTEM. Classified as Programmer, Changer, Film/cassette, Radiographic (product code IZP), Class II - Special Controls.

Submitted by Medrad, Inc. (Pittsburgh, US). The FDA issued a Cleared decision on February 11, 1988 after a review of 106 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1870 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Medrad, Inc. devices

FDA 510(k) Submission Details - K874451

510(k) Number K874451 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 28, 1987
Decision Date February 11, 1988
Days to Decision 106 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
1d faster than avg
Panel avg: 107d · This submission: 106d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IZP Device Classification - Class 2, Special Controls

Product Code IZP Programmer, Changer, Film/cassette, Radiographic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1870
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.