Cleared Traditional

K912180 - MODEL MGB-301 DIAPHRAGM FILM 24 X 30 CM (FDA 510(k) Clearance)

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

K912180 · Instrumentarium Imaging, Inc. · Radiology device
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Oct 1991
Decision
158d
Days
Class 2
Risk

K912180 is an FDA 510(k) clearance for the MODEL MGB-301 DIAPHRAGM FILM 24 X 30 CM. Classified as Collimator, Manual, Radiographic (product code IZX), Class II - Special Controls.

Submitted by Instrumentarium Imaging, Inc. (Milwaukee, US). The FDA issued a Cleared decision on October 21, 1991 after a review of 158 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1610 - 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 Instrumentarium Imaging, Inc. devices

Submission Details

510(k) Number K912180 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 16, 1991
Decision Date October 21, 1991
Days to Decision 158 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
51d slower than avg
Panel avg: 107d · This submission: 158d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code IZX Collimator, Manual, Radiographic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1610
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.