Cleared Traditional

K912180 - MODEL MGB-301 DIAPHRAGM FILM 24 X 30 CM

K912180 is an FDA 510(k) clearance for MODEL MGB-301 DIAPHRAGM FILM 24 X 30 CM, manufactured by Instrumentarium Imaging, Inc.. The device is a Class 2 Radiology device with product code IZX cleared through the Traditional 510(k) pathway after a 158-day FDA review.

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

FDA 510(k) Submission Details - K912180

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
Combination Product No
PCCP Authorized No
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.

IZX Device Classification - Class 2, Special Controls

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.